FDA.reportPublic FDA data

GCB Medical Supply

Primary DI
00810184641070
Brand
GCB Medical Supply
Company
GCB MEDICAL LLC
Model
GCB2211
Catalog number
GCB2211
Device description
GCB MEDICAL BOOT COVER UNIVERSAL
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWPShoe And Shoe Cover, Conductive
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWPShoe And Shoe Cover, ConductiveGeneral, Plastic Surgery1
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184641445PackageGS1100In Commercial Distribution
00810184641070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184641445008101846414458101846414450810184641445
00810184641070008101846410708101846410700810184641070

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
8334226331info@gcbmedicalsupply.com

Regulatory Flags#

DUNS number
086699722
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810184642152GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642169GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642176GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184642213GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642220GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642237GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184641292GCB Medical SupplyGCB941GCB9412025-07-31
00810184641308GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641315GCB Medical SupplyGCB942GCB9422025-07-31
00810184641667GCB Medical SupplyGCB941GCB9412025-07-31
00810184641674GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641681GCB Medical SupplyGCB942GCB9422025-07-31
00810184641322GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859006GCB Medical SupplyGCB0288GCB02882025-07-29
00850061859228GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184641698GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859105GCB Medical SupplyGCB0288GCB02882025-07-29
10850061859225GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184640974GCB Medical SupplyGCB0210BXGCB0210BX2025-07-24
00810184640981GCB Medical SupplyGCB0212GCB02122025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330706596ProCureTwin Med, LLCBWP2026-05-05
10817583020342Critical CoverAlpha Pro Tech, Inc.BWP2026-04-16
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