FDA.reportPublic FDA data

AMG

Primary DI
00850017650695
Brand
AMG
Company
ARROW MEDSOURCE GROUP LIMITED
Model
BC0001
Published
2020-08-06
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
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
10850017650692PackageGS13In Commercial Distribution
00850017650695PrimaryGS10
00850017650688Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001765069210850017650692
00850017650695008500176506958500176506950850017650695
00850017650688008500176506888500176506880850017650688

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
686378503
Device count
50
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810069260327AMG9500-N952021-01-27
00850017650305AMGBCPB001XL2020-06-22
00850017650343AMGBCRW001XL2020-06-22
00850017650671AMGSCP00012020-08-06
00810069260358AMG60022021-03-08
00810069260365AMG60032021-03-09
00810069260372AMG60112021-03-09
00810069260389AMG60122021-03-09
00810069260396AMG60132021-03-09
00810069260341AMG60012021-03-09
00810069260402AMG20112021-05-14
00810069260419AMG20122021-05-14
00810069260426AMG20132021-05-14
00810069260433AMG20142021-05-14
00810069260440AMG20152021-05-14
00810069260457AMG20162021-05-14
10810069260409AMG20112021-05-14
10810069260416AMG20122021-05-14
10810069260423AMG20132021-05-14
10810069260430AMG20142021-05-14

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
00850061859136GCB 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