AccessGUDID - DEVICE: Critical Cover (10817583020731)

GUDID

Device Identifier (DI) Information

Brand Name: Critical Cover
Version or Model: SH-12522-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SH-12522-B
Company Name: Alpha Pro Tech, Inc.

Primary DI Number: 10817583020731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 102710720 *Terms of Use

Device Description: Shoe Cover, SureGrip, Conductive for ESD concerns, Anti-Skid, Serged Seams, Blue, Universal.

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):	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?
13575	Shoe cover, conductive, non-sterile	A non-sterile device made of conductive material designed to reduce the risk of static electricity build-up and intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BWP	Shoe And Shoe Cover, Conductive

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: 4a7d50c7-fbc6-4023-b786-31038f2f4ffb
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: July 16, 2018