For personal lubricant and condom brands that label their own devices

The new 8 oz bottle went to print with the 4 oz barcode.

Slate keeps each version’s device identifier, its label proof and its GUDID record, and every change to it — and will not release a version for labeling while its identifier is missing, invalid or shared with another size or formula, its GUDID record is late, or a change was not updated in time.

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Opens in this browser with an invented brand already in it. No account, no email address, nothing installed.

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The problem

Each version is its own record.

The labeler of a device that must bear a unique device identifier submits each version or model to FDA’s GUDID, no later than the date the label must first bear the identifier, and keeps it current. A new size or a new formula is a new version with its own identifier. The failure is a new bottle printed with an old barcode, or a change nobody updated.

Each version

the labeler provides the GUDID data for each version or model required to bear a UDI.

21 CFR 830.300 →

By the label

the data is due no later than the date the label must bear the identifier, and label changes by the date first labeled.

21 CFR 830.330 →

10 days

for a change that is not on the label, the update is due within ten business days.

21 CFR 830.330 →

Will not release a version without its own record.

Not a reminder. Release for labeling refuses, naming the problem, while the device identifier is missing, fails the GTIN check digit or is on another version; there is no label proof; the GUDID record is not published or was published after first labeling; or a change was not updated in GUDID in time. A released version is frozen. There is no override.

How it works

Identifier, proof, record

Give each version its identifier

One GTIN per size and formula, checked digit by digit.

File the proof

The signed label proof that carries it.

Publish, then release

Record the GUDID publication date and every change, then release for labeling when everything is in time.

What it will never do

It keeps your records. It submits nothing to FDA.

Slate uses the identifiers and dates you give it.

No GUDID connection.Nothing is submitted or looked up. You record what GUDID shows.

It issues no barcodes.Your identifiers come from your GS1 account.

It is not regulatory advice.It is the record and the check.

It never touches a payment.The subscription is for software.

Pricing

Priced per brand

Less than one reprinted label run.

Most brands

Brand

$15/month

One labeler.

Every version and its identifier
Release gate, no override
Change deadlines counted

Portfolio

$39/month

Several brands or a contract labeler.

Everything in Brand
Many labelers
Export per brand

Monthly subscription. Your bank statement says Slate Software. Your licence key is emailed to you within two working days of payment.

Checkout is our own bitcoin server, not a card processor — nobody we had to apply to and nobody who can close the account. The button takes you straight to it. Give your email address there — that is where your key is sent.

Questions

The ones we actually get asked

Does a new size need a new identifier?

A different version or model is its own record. Slate refuses to release two versions sharing one identifier.

How are business days counted?

Slate skips weekends. Count federal holidays yourself.

Is this regulatory advice?

No. It is the record you keep and a check you cannot skip.

What do I actually get when I pay?

The demo on this page is the whole program, running on invented records. Paying gets you a licence key — one line of text, emailed to the address you give at checkout within two working days. Paste it into the program and from then on it keeps your own records. Until then, nothing you type into it is kept.

The key is checked inside the page, on your own machine. It never calls us, so there is still no account and nothing about your business goes anywhere. If you ever stop paying, your records stay exactly where they are, read-only, and Export still hands you every one of them.

Open the demo before the next print run

The 4 oz bottle is released. The new 8 oz carries the 4 oz bottle’s identifier and has no GUDID record. The silicone 2 oz was published a week after it was labeled, and the warming gel’s shelf-life change was never updated.

Open the demo See pricing