AccessGUDID - DEVICE: CARDINAL HEALTH (10885425500642)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 23626-540
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 23626-540
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885425500642
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: STERILE CAST PADDING KIT

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?
60369	General-purpose medical fibre padding, sterile	A sterile roll, sheet or preformed shape of fibres (e.g., polyester) intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., padding under casts and compression dressings), typically over intact and healthy skin. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITG	BANDAGE, CAST

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: bf364a06-7617-4aaa-92cb-f8e7f9e9d1ed
Public Version Date: December 31, 2020
Public Version Number: 3
DI Record Publish Date: October 01, 2018