FDA.reportPublic FDA data

SafeSource Shoe Covers

Primary DI
00850037747269
Brand
SafeSource Shoe Covers
Company
Safesource Direct, L.L.C.
Model
SC3001
Device description
Universal Blue Shoe Covers
Published
2023-05-16
Public version status
Update
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
10850037747266PackageGS14In Commercial Distribution
00850037747269PrimaryGS10
00850037747627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003774726610850037747266
00850037747269008500377472698500377472690850037747269
00850037747627008500377476278500377476270850037747627

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3372107920general@safesourcedirect.com

Regulatory Flags#

DUNS number
118070602
Device count
100
Premarket exempt
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
00850037747474Universal Shoe Cover Super TreadSC30032024-10-10
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
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