AccessGUDID - DEVICE: CARDINAL HEALTH & Design (20885380070614)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 20885380070614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: EYEWEAR FRAME CARDINAL HEALTH FOR CAH LENS DISPOSABLE

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):	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?
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

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: f5acc49f-36d1-42db-9ce4-fdd39bbb6aab
Public Version Date: July 07, 2020
Public Version Number: 3
DI Record Publish Date: May 25, 2018