AccessGUDID - DEVICE: CARDINAL HEALTH (20885380041096)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 4859SS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4859SS
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20885380041096
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: SHOE COVER WITH ANTI-SKID, SMS, SPO

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?
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXP	COVER, SHOE, OPERATING-ROOM

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: 5a2984c2-27d4-4afd-8eed-23c4d06cc72b
Public Version Date: November 04, 2024
Public Version Number: 4
DI Record Publish Date: November 14, 2018