AccessGUDID - DEVICE: Tissue-Tek® SmartWrite® (10615233082456)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® SmartWrite®
Version or Model: 9030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9030
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 10615233082456
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: Slide and Cassette Print Cartridge Black; 6/case

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?
62926	Microscope slide labelling cartridge IVD	A device designed to be inserted into an automated microscope slide processing instrument (e.g., printer, stainer, or maker) to label a microscope slide for specimen identification prior to blood smearing. It is a casing, similar to a paper printer cartridge, with a printer ribbon that makes thermal contact with the slide, with heat and printed data from the processing instrument, to transfer information to the slide.	Active	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: 0593f2ed-c5de-4bcb-b77c-196ef434aad1
Public Version Date: February 24, 2020
Public Version Number: 1
DI Record Publish Date: February 16, 2020