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Tissue-Tek® SmartWrite®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Tissue-Tek® SmartWrite® FDA UDI
Generic Name
Laboratory specimen/material barcode label FDA UDI
Device Name
2D Barcode Scanner and Stand FDA UDI
Model / Reference
9024 FDA UDI
Description
2D Barcode Scanner and Stand FDA UDI

Identifiers

Catalog Number
9024 FDA UDI
Primary DI / UDI-DI
00615233082411 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
Laboratory specimen/material barcode label FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory specimen/material barcode labelBarcode reader mount

Tissue-Tek® SmartWrite® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barcode reader mount.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 694ed3fd-095f-4eef-948e-973c4f7f9eeb 35 fields · synced May 30, 2026