AccessGUDID - DEVICE: American White Cross (10665973018093)

GUDID

Device Identifier (DI) Information

Brand Name: American White Cross
Version or Model: 17570 and 17571
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17570 and 17571
Company Name: Dukal LLC

Primary DI Number: 10665973018093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791014871 *Terms of Use

Device Description: Eye Pad 2-1/8" x 2-5/8", Sterile

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?
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: 6228abaf-5e76-41e4-8462-0545bfc76b07
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30665973018097	24	20665973018090	In Commercial Distribution	Case
20665973018090	50	10665973018093	In Commercial Distribution	Box
40665973018094	500	10665973018093	In Commercial Distribution	Case