FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216118317
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
CST207-CV3
Device description
SHOE COVER, UNIVERSAL, BLUE,SBPP, 44X18CM, 100EA/BG, 10BG/CS
Published
2022-06-22
Public version status
Update
Distribution status
Not 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
00840216118317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216118317008402161183178402161183170840216118317

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

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09

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