Model: PR-Shoe Covers
Catalog: PR-SCGT01
DI: 00688162000665
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Shoe Cover, PP&PE, Grey, Large
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9c900273-4dee-46ad-a907-b238a5407c29
Distribution Status:
In Commercial Distribution
DUNS Number:
078780963
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00688162000665
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 15056
Name: Shoe cover
Definition:
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.
FDA Product Codes
BWP
Shoe And Shoe Cover, Conductive