FDA.reportPublic FDA data

Universal Shoe Cover Super Tread

Primary DI
00850037747474
Brand
Universal Shoe Cover Super Tread
Company
Safesource Direct, L.L.C.
Model
SC3003
Device description
Universal Size Blue Shoe Cover with Tread
Published
2024-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037747471PackageGS14In Commercial Distribution
00850037747474PrimaryGS10
20850037747478Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003774747110850037747471
00850037747474008500377474748500377474740850037747474
2085003774747820850037747478

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA 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.

Contacts#

Phone, Email table
PhoneEmail
3372107920general@safesourcedirect.com

Regulatory Flags#

DUNS number
118070602
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037747467Extra Large Blue Shoe CoverSC30022024-10-10
00850037747481Extra Large Extra Traction Shoe CoverSC30042024-10-10
10850037747464Extra Large Blue Shoe CoverSC30022024-10-10
10850037747471Universal Shoe Cover Super TreadSC30032024-10-10
10850037747488Extra Large Extra Traction Shoe CoverSC30042024-10-10
00850037747221"Bouffant Cap 21"" White"BHC30021WE2024-10-01
00850037747238"Bouffant Cap 21"" Blue"BHC30021BE2024-10-01
00850037747245"Bouffant Cap 24"" White"BHC30024WE2024-10-01
00850037747252"Bouffant Cap 24"" Blue"BHC30024BE2024-10-01
10850037747228Bouffant Cap 21" WhiteBHC30021WE2024-10-01
10850037747235Bouffant Cap 21" BlueBHC30021BE2024-10-01
10850037747242Bouffant Cap 24" WhiteBHC30024WE2024-10-01
10850037747259Bouffant Cap 24" BlueBHC30024BE2024-10-01
00850037747382Plant Based Procedural MaskPM3003-W-ECO2024-04-05
00850037747122SafeSource Direct Level 1 Surgical Mask with TiesSM30012023-05-16
00850037747139SafeSource Direct Level 3 Surgical Mask with TiesSM30032023-05-16
00850037747146SafeSource Direct Level 1 Procedure Mask with Ear LoopsPM30012023-05-16
00850037747269SafeSource Shoe CoversSC30012023-05-16
00850037747153SafeSource Direct Level 3 Procedure Mask with Ear LoopsPM30032023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19
30080196745795MedlineMEDLINE INDUSTRIES, INC.FXP2023-10-12
10810141930435VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930442VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930626Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930633Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930923VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930930VIVIT SupplyVivit Supply LLCFXP2023-09-15
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10097604469750Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10849233004877Busse Hospital DisosablesROBERT BUSSE & CO., INC.FXP2023-06-16
10849233005003Busse Hospital DisposablesROBERT BUSSE & CO., INC.FXP2023-06-16
10097604470022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604472248Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604474754Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10850044799586SURGYCOSurgyco LLCFXP2023-02-16
20192253063322CARDINAL HEALTHCardinal Health 200, LLCFXP2023-01-13
10810087350175CoulmedCoulmed Products Group LLCFXP2023-01-06