FDA.reportPublic FDA data

OPERATING-ROOM SHOE COVER

Primary DI
06950471300076
Brand
OPERATING-ROOM SHOE COVER
Company
Hangzhou A-Tek Medical & Textiles Co., Ltd.
Model
28024
Device description
OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
06950471300076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950471300076069504713000766950471300076

GMDN Terms#

Term, Definition table
TermDefinition
Medical shoeA footwear designed as a washable shoe available in various forms intended to be worn in pairs in a medical setting. 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547874292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950471300137DISPOSABLE HOT OR COLD PACK COVER280302023-07-21
06950471300144VACUUM COLLECTION BOTTLE280312023-07-21
06950471300151GAS COLLECTING VESSEL280322023-07-21
06950471300038DISPOSABLE BEDDING PRODUCTS280202023-07-18
06950471300045EXAMINATION GOWN280212023-07-18
06950471300052SURGICAL CAP280222023-07-18
06950471300069SURGICAL APPAREL ACCESSORY280232023-07-18
06950471300083SURGICAL GOWN280252023-07-18
06950471300106NON-SURGICAL ISOLATION GOWN280272023-07-18
06950471300113TABLE TRAY FOR OPERATING ROOM280282023-07-18
06950471300120CONDUCTIVE SHOE AND SHOE COVER280292023-07-18
06950471320067RESUABLE INCONTINENCE UNDERPAD280192023-07-18

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