AccessGUDID - DEVICE: CARDINAL HEALTH (10197106530399)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: SEY3WEYJA8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SEY3WEYJA8
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10197106530399
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: EYE PACK

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
40511	Hygiene apron, single-use	A non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJK	Eye tray

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
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8444fc92-c6df-494b-8990-f31d35804cc7
Public Version Date: January 24, 2024
Public Version Number: 1
DI Record Publish Date: January 16, 2024