FDA.reportPublic FDA data

Topmed

Primary DI
06975889410049
Brand
Topmed
Company
XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO.,LTD
Model
Universal
Published
2022-12-20
Public version status
New
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
06975889410049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975889410049069758894100496975889410049

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
547862097
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975889410087TopmedA0372023-05-23
06975889410094TopmedM20032024-01-12
06975889410100TopmedM20012024-01-12
06975889410117TopmedM20042024-01-12
06975889410070TopmedB90012023-05-23
06975889410032Topmed"19"" 21"" 24"" 64x14cm"2022-12-20
06975889410056TopmedS,M,L,XL,XXL,XXXL2022-12-20
06975889410063TopmedM40062022-12-20
06975889410025TopmedG40032022-12-19
06975889410018TopmedEarloop2022-12-16

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