AccessGUDID - DEVICE: Tissue-Tek® SmartWrite® (00615233082411)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® SmartWrite®
Version or Model: 9024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9024
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233082411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: 2D Barcode Scanner and Stand

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62002	Laboratory specimen/material barcode label	A label (e.g., a card or insert) featuring a barcode intended to facilitate clear and easy identification of a laboratory specimen and/or material (e.g., a clinical specimen or assay reagent/buffer in a container). It is electronically readable using a computerized reader or scanner, either on-board or connected to an instrument or analyser. This is a reusable device.	Active	false
61297	Barcode reader mount	A device intended to hold and secure a barcode reader in a position to facilitate its use when required. It is typically made of plastic and affixed to a wall or laboratory instrument.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 694ed3fd-095f-4eef-948e-973c4f7f9eeb
Public Version Date: February 20, 2023
Public Version Number: 2
DI Record Publish Date: February 16, 2020