FDA.reportPublic FDA data

SOURCE SURGICAL INC.

Primary DI
74895237141474
Brand
SOURCE SURGICAL INC.
Company
KENPAX INTERNATIONAL LIMITED
Model
1
Catalog number
68-3230-B
Device description
Shoe coverA non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.
Published
2021-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
84895237141471PackageGS1400In Commercial Distribution
74895237141474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8489523714147184895237141471
7489523714147474895237141474

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.

Regulatory Flags#

DUNS number
686206765
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
74895237104134CustoMed168-324B-PC2020-07-16
74895237141146CustoMed168-321G-PC2020-07-16
74895237141153CustoMed168-331B-NC2020-07-16
74895237141450SOURCE SURGICAL INC.168-2210-W2021-03-15
74895237141467SOURCE SURGICAL INC.168-2220-W2021-03-15
74895237104110Customed168-101B-UC2020-07-16
74895237108019SURGIPLUS168-7171-B2020-07-22
74895237108026SURGIPLUS168-7172-B2020-07-22
74895237108033SURGIPLUS168-7173-B2020-07-22
74895237108040SURGIPLUS168-7174-B2020-07-22
74895237108057SURGIPLUS168-7175-B2020-07-22
74895237108071SURGIPLUS168-7177-B2020-07-29
74895237108088SURGIPLUS168-7176-B2020-07-22
74895237108095SURGIPLUS168-7178-B2020-07-29
74895237141528SURGIPLUS168-6148-B2021-03-15
74895237141535SURGIPLUS168-6149-B2021-03-15
04895237141161CustoMed110030922020-07-16
04895237141178CustoMed110042922020-07-16
04895237141185CustoMed110042932020-07-16
04895237141192CustoMed11007802020-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456217566JMUJMU DENTAL, INCFXP2026-07-07
00860012300792JMUJMU DENTAL, INCFXP2026-07-07
00199536901209BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901216BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901223BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901230BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901247BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901254BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901261BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901278BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
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