FDA.reportPublic FDA data

Critical Cover

Primary DI
10817583021042
Brand
Critical Cover
Company
Alpha Pro Tech, Inc.
Model
SH-T1182-B
Catalog number
SH-T1182-B
Device description
Shoe Cover, AquaTrak, Fluid Resistant, Butterfly Style, Seamless Sole, Serged Seams, White, Universal.
Published
2018-07-16
Public version status
Update
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
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
20817583021049PackageGS11In Commercial Distribution
10817583021042PrimaryGS10
00817583021045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302104920817583021049
1081758302104210817583021042
00817583021045008175830210458175830210450817583021045

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
1-520-281-0127XX@XX.XX

Regulatory Flags#

DUNS number
102710720
Device count
150
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817583020342Critical CoverSH-12524-BSH-12524-B2026-04-16
10817583020731Critical Cover SH-12522-B SH-12522-B2018-07-16
10817583020748Critical Cover SH-12523-B SH-12523-B2018-07-16
10817583020304Critical CoverGR5005GR50052016-11-03
10817583020311Critical CoverPK5005PK50052016-11-03
10817583020335Critical CoverBL5100BL51002016-11-03
10817583020564Critical CoverBL5500BL55002016-11-03
10817583020625Critical Cover1008 Biotrol1008 Biotrol2016-11-03
00817583020635Critical Cover1008 COTT BULK1008 COTT BULK2016-11-03
00817583020642Critical Cover1015 COTT BULK1015 COTT BULK2016-11-03
10817583020236Critical CoverGR6055GR60552016-11-03
10817583020137Critical Cover695CRX695CRX2016-11-03
10817583020243Critical CoverPK6055PK60552016-11-03
10817583020250Critical CoverYL6055YL60552016-11-03
10817583020595Critical CoverBL6155BENBL6155BEN2016-11-15
10817583020601Critcal CoverPK6155-BENPK6155-BEN2016-11-15
10817583020618Critical CoverWH6155BENWH6155BEN2016-11-15
10817583020687Critical Cover MS-01J76-4ST MS-01J76-4ST2018-07-16
10817583020694Critical Cover MS-01J76-8ST MS-01J76-8ST2018-07-16
10817583023329Critical Cover9400 Veil9400 Veil2020-12-18

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