AccessGUDID - DEVICE: Tissue-Tek® SmartWrite® (00615233082404)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® SmartWrite®
Version or Model: 9023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9023
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233082404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: AutoLoader

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?
61864	Cell morphology analyser IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.	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: 188895c0-928b-4d06-8bae-741f54d878f4
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: February 16, 2020