Model: PC631
Catalog: PC631
DI: 10840330706596
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Shoe Covers, Non-Skid, Blue 50pr/bg 10bg/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3bcb57b4-2c54-4df5-a0a4-b0a7484c220e
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
100
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10840330706596
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840330706599
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
30840330706590
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10840330706596
Item #3 - Device ID 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