FDA.reportPublic FDA data

Critical Cover

Primary DI
10817583020700
Brand
Critical Cover
Company
Alpha Pro Tech, Inc.
Model
MS-14138-8
Catalog number
MS-14138-8
Device description
Beard Cover, GenPro, Lightweight, 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
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817583020707PackageGS110In Commercial Distribution
10817583020700PrimaryGS10
00817583020703Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302070720817583020707
1081758302070010817583020700
00817583020703008175830207038175830207030817583020703

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hoodA non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-520-281-0127XX@XX.XX

Regulatory Flags#

DUNS number
102710720
Device count
100
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

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Primary DI, Brand, Company table
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00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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