AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810077219959)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: VKAEP480
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00810077219959
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 480
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: Adhesive Eye Patch

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":	Yes
For Single-Use:	Yes
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?
61490	Eye patch	A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMP	PAD, EYE

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: 6f3ebc53-e56e-48a2-b9d8-c58c66be3beb
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 04, 2023