AccessGUDID - DEVICE: Batrik ShoozCovers™ (00690521022690)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik ShoozCovers™
Version or Model: SC-2122-NPB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC-2122-NPB
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521022690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: "ShoozCovers™ Disposable Shoe Covers, X-Large, Marshmallow White, Waterproof Shoe size 12 – 15, ~ 47 cm x 17.5 cm / 18.5” 6.9”"

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):	No
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
Special Storage Condition, Specify: Store in a cool dry place
Special Storage Condition, Specify: Store away from heat and sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31e73ac8-b03b-44f0-9f5c-4ce0ae7da32e
Public Version Date: February 24, 2025
Public Version Number: 1
DI Record Publish Date: February 14, 2025