AccessGUDID - DEVICE: Blake Kuwahara (00810110313828)

GUDID

Device Identifier (DI) Information

Brand Name: Blake Kuwahara
Version or Model: Stanton-Mtte Blk
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fade To Grey Corp.

Primary DI Number: 00810110313828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080287087 *Terms of Use

Device Description: STANTON - Matte Black - 53 * 21 - 140

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?
32816	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQZ	Frame, Spectacle

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: 27d7f36c-7fec-45c4-b11c-8ce77327463f
Public Version Date: August 09, 2022
Public Version Number: 1
DI Record Publish Date: August 01, 2022

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
HIBCC	G131STANTONMB0

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: No
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: 000-000-0000
Email: gudid@blakekuwahara.com

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