AccessGUDID - DEVICE: Critical Cover (10817583021141)

GUDID

Device Identifier (DI) Information

Brand Name: Critical Cover
Version or Model: SH-X1273-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SH-X1273-B
Company Name: Alpha Pro Tech, Inc.

Primary DI Number: 10817583021141
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, Anti-Skid, Serged Seams, Gaylord Packaging, Blue, XL.

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?
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: a7bb33b0-7cd0-4b7c-9af6-6c139e586558
Public Version Date: June 09, 2025
Public Version Number: 3
DI Record Publish Date: July 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20817583021148	30	10817583021141		In Commercial Distribution	Gaylord

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00817583021144 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-520-281-0127
Email: XX@XX.XX

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