AccessGUDID - DEVICE: Eye Pads - 10/Box (00766588311159)

GUDID

Device Identifier (DI) Information

Brand Name: Eye Pads - 10/Box
Version or Model: R231-115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R231-115
Company Name: Certified Safety Manufacturing, Inc.

Primary DI Number: 00766588311159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788460483 *Terms of Use

Device Description: Eye Pads - 10/Box

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 [?]
K940333	000

Device Exempt from Premarket Submission: No 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: e0ec51b0-5ff4-488f-943d-caad5c101db8
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 27, 2023