FDA.reportPublic FDA data

Critical Cover

Primary DI
20817583023319
Brand
Critical Cover
Company
ALPHA PRO TECH INC
Model
1807
Catalog number
1807
Device description
Full Face Shield, anti-fog, foam strip, attached comfort headband with snaps
Published
2020-12-18
Public version status
New
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
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875302000MEDICAL EYE DISPOSABLE SHIELDBfd, Inc.1988-03-21HOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817583023319PackageGS14In Commercial Distribution
10817583023312PrimaryGS10
00817583023315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302331920817583023319
1081758302331210817583023312
00817583023315008175830233158175830233150817583023315

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, single-useA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. 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
25
DM exempt
false
Premarket exempt
false
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
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
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00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
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00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29
00630094053707Bioseal Inc.BIOSEALHOY2024-01-26
00630094053738Bioseal Inc.BIOSEALHOY2024-01-26
00630094053905Bioseal Inc.BIOSEALHOY2024-01-26
00630094540016Bioseal Inc.BIOSEALHOY2024-01-26
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
00630094183411Bioseal Inc.BIOSEALHOY2023-10-05
00630094183459Bioseal Inc.BIOSEALHOY2023-10-05