AccessGUDID - DEVICE: Tissue-Tek® Glas™ g2 (00615233080776)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® Glas™ g2
Version or Model: 6503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6503
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233080776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: Glass Coverslipper with Barcode System

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?
37035	Barcode reader	A device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required.	Active	false
61826	Microscope slide coverslipper IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to apply a coverslip over a microscope examination slide to protect the fixed/stained specimen from mechanical forces or environmental exposure prior to microscopic examination and/or long-term storage of the slide. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIM	DEVICE FOR SEALING MICROSECTIONS

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: 072a091d-d3f4-47d2-9317-78f0a9363c49
Public Version Date: March 25, 2020
Public Version Number: 1
DI Record Publish Date: March 17, 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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