FDA.reportPublic FDA data

Critical Cover

Primary DI
20817583021025
Brand
Critical Cover
Company
ALPHA PRO TECH INC
Model
SH-M1315-BH
Catalog number
SH-M1315-BH
Device description
Shoe Cover, UltraGrip, BarrierTech Upper, Anti-Skid Sole, Serged Seams, Blue, Medium.
Published
2018-07-16
Public version status
Update
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
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
20817583021025PackageGS11In Commercial Distribution
10817583021028PrimaryGS10
00817583021021Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302102520817583021025
1081758302102810817583021028
00817583021021008175830210218175830210210817583021021

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

Regulatory Flags#

DUNS number
003687733
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20817583020752Critical Cover SH-71222-B SH-71222-B2018-07-16
20817583020769Critical CoverSH-71223-BSH-71223-B2018-07-16
20817583020776Critical Cover SH-91182-B SH-91182-B2018-07-16
20817583020790Critical Cover SH-91183-B SH-91183-B2018-07-16
20817583020813Critical Cover SH-91184-B SH-91184-B2018-07-16
20817583020837Critical Cover SH-C1103-B SH-C1103-B2018-07-16
20817583020844Critical Cover SH-E1312-BH SH-E1312-BH2018-07-16
20817583020868Critical Cover SH-E1315-BH SH-E1315-BH2018-07-16
20817583020882Critical Cover SH-E1712-BH SH-E1712-BH2018-07-16
20817583020899Critical Cover SH-E1713-BH SH-E1713-BH2018-07-16
20817583020905Critical Cover SH-E1715-BH SH-E1715-BH2018-07-16
20817583020912Critical Cover SH-E1716-BH SH-E1716-BH2018-07-16
20817583020929Critical Cover SH-E1W11-BH SH-E1W11-BH2018-07-16
20817583020936Critical Cover SH-E1W12-BH SH-E1W12-BH2018-07-16
20817583020943Critical Cover SH-E1W13-BH SH-E1W13-BH2018-07-16
20817583020950Critical Cover SH-E1W15-BH SH-E1W15-BH2018-07-16
20817583020974Critical Cover SH-G1253-B SH-G1253-B2018-07-16
20817583020981Critical Cover SH-H1253-B SH-H1253-B2018-07-16
20817583021001Critical Cover SH-M1312-BH SH-M1312-BH2018-07-16
20817583021018Critical Cover SH-M1313-BH SH-M1313-BH2018-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10097604469750Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10849233004877Busse Hospital DisosablesROBERT BUSSE & CO., INC.FXP2023-06-16
10849233005003Busse Hospital DisposablesROBERT BUSSE & CO., INC.FXP2023-06-16
10097604470022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604472248Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604474754Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10850044799586SURGYCOSurgyco LLCFXP2023-02-16
20192253063322CARDINAL HEALTHCardinal Health 200, LLCFXP2023-01-13
10810087350175CoulmedCoulmed Products Group LLCFXP2023-01-06