FDA.report

Critical Cover

Primary DI
20817583022992
Brand
Critical Cover
Company
ALPHA PRO TECH INC
Model
MS-01135-8
Catalog number
MS-01135-8
Device description
Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV
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

Related Records

Contact Domains

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817583022992PackageGS11In Commercial Distribution
10817583022995PrimaryGS10
00817583022998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302299220817583022992
1081758302299510817583022995
00817583022998008175830229988175830229980817583022998

GMDN Terms

TermDefinition
Surgical sleeve coverA forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
003687733
Device count
100
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 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
10817583020854Critical Cover SH-E1313-BH SH-E1313-BH2018-07-16
20817583020868Critical Cover SH-E1315-BH SH-E1315-BH2018-07-16
10817583020878Critical Cover SH-E1316-BH SH-E1316-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

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