AccessGUDID - DEVICE: Tissue-Tek® (00615233007278)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek®
Version or Model: 5993
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5993
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233007278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: 10% Neutral Buffered Formalin

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?
57757	10% Neutral buffered formalin IVD	A 10% neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General purpose reagent

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: dcc12fee-177b-4a93-a9fb-0c1d5a0bc2be
Public Version Date: September 14, 2020
Public Version Number: 1
DI Record Publish Date: September 05, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00615233007117 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(310)972-7800
Email: TS@sakuraus.com

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