Device
Shoe Cover, Non Skid, SMS, Blue, XX-Large
Manufacturer
Transparent Supply Solutions Ltd.
Model: 2282 DI: 00199536901254 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
Shoe Cover, Non Skid, SMS, Blue, XX-Large
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 502d96bb-483d-4117-bcbe-50964677ccbd
Distribution Status: In Commercial Distribution
DUNS Number: 119522714
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: Yes
Identifiers
Item #1 - Pkg Type: BOX
Item #1 - Device ID: 30199536901255
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 100
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00199536901254
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00199536901254
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: CASE
Item #3 - Device ID: 50199536901259
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 3
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 30199536901255
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
FXP
Cover, Shoe, Operating-Room