AccessGUDID - DEVICE: Vera Bradley (00781096533008)

GUDID

Device Identifier (DI) Information

Brand Name: Vera Bradley
Version or Model: VB Fern Paisley in Paradise
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VBFERN0PYP053S16
Company Name: MCGEE GROUP, INC., THE

Primary DI Number: 00781096533008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 847029543 *Terms of Use

Device Description: Spectacle Frame, Size 53-16-135

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):	Yes
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
HQR	Apparatus, cautery, radiofrequency, ac-powered

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: f499d0ce-2f21-40ac-ac16-d1e1b994476a
Public Version Date: November 04, 2019
Public Version Number: 1
DI Record Publish Date: October 25, 2019