AccessGUDID - DEVICE: Medi-First Eye Pads (00347682644703)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-First Eye Pads
Version or Model: 64470
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 64470
Company Name: Medique Products

Primary DI Number: 00347682644703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086911794 *Terms of Use

Device Description: A pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

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:	Yes
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?
11661	Eye pad	A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. 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: Yes
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: e2bee922-95e5-403a-938c-816ef3d4e689
Public Version Date: July 29, 2019
Public Version Number: 1
DI Record Publish Date: July 19, 2019