AccessGUDID - DEVICE: Tissue-Tek® Lab Aid® (08720177655613)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® Lab Aid®
Version or Model: 4012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4012
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 08720177655613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: Top Panel, Green

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?
35976	Microscope slide cabinet	A furniture-like device designed for the secure storage of many prepared laboratory specimen slides, e.g., histology microscope slides. The slides will typically be placed in dedicated trays. This device may be used, e.g., in the laboratory or a physician's office and can be locked to prevent access by an unauthorized person.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNK	CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

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: 104dde05-bca3-4a82-9ead-02afc08abf84
Public Version Date: June 29, 2020
Public Version Number: 1
DI Record Publish Date: June 20, 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: No Unit of Use DI Numbers Found 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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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