FDA.reportPublic FDA data

GCB Medical Supply Novaplus

Primary DI
00850061859136
Brand
GCB Medical Supply Novaplus
Company
GCB MEDICAL LLC
Model
VGCB0211
Catalog number
VGCB0211
Device description
GCB MEDICAL NOVAPLUS UNIVERSAL, NON SKID SHOE COVER
Published
2025-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWPShoe And Shoe Cover, Conductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWPShoe And Shoe Cover, ConductiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061859136PackageGS110In Commercial Distribution
00850061859037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061859136008500618591368500618591360850061859136
00850061859037008500618590378500618590370850061859037

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
(833) 422-6331info@gcbmedicalsupply.com

Regulatory Flags#

DUNS number
086699722
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00688162000665ProtexerICP MEDICAL, LLCBWP2026-04-27
00688162000672ProtexerICP MEDICAL, LLCBWP2026-04-27
10817583020342Critical CoverAlpha Pro Tech, Inc.BWP2026-04-16
00688162000023ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021789ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021796ProtexerICP MEDICAL, LLCBWP2025-08-19
10688162000020ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021786ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021793ProtexerICP MEDICAL, LLCBWP2025-08-19
00810184641032GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641049GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641056GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641063GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641070GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641087GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642589GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642596GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641407GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641414GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641421GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641438GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641445GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641452GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642763GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642770GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00850061859037GCB Medical Supply NovaplusGCB MEDICAL LLCBWP2025-07-23
TQ26126151041Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.BWP2024-12-09
TQ26126151040Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.BWP2024-12-09
06950471300076OPERATING-ROOM SHOE COVERHangzhou A-Tek Medical & Textiles Co., Ltd.BWP2023-07-18