Critical Cover - Sleeve Protector, GenPro, White, Serged Seams, - ALPHA PRO TECH INC

Duns Number:003687733

Device Description: Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV

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More Product Details

Catalog Number

MS-01135-8

Brand Name

Critical Cover

Version/Model Number

MS-01135-8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Device Record Status

Public Device Record Key

1ad61a37-a2e2-4c01-a7ee-beb79f70e3c9

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

20817583022992

Quantity per Package

1

Contains DI Package

10817583022995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ALPHA PRO TECH INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 17