Critical Cover - Boot Cover, MaxGrip, Elastic Top and Ankle, - ALPHA PRO TECH INC

Duns Number:003687733

Device Description: Boot Cover, MaxGrip, Elastic Top and Ankle, Anti-Skid Sole, Serged Seams, White, Universal Boot Cover, MaxGrip, Elastic Top and Ankle, Anti-Skid Sole, Serged Seams, White, Universal.

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More Product Details

Catalog Number

BT-T5W12-B

Brand Name

Critical Cover

Version/Model Number

BT-T5W12-B

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

FXP

Product Code Name

Cover, Shoe, Operating-Room

Device Record Status

Public Device Record Key

b6d22665-5606-4462-9071-2fff7f7fa67d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2018

Additional Identifiers

Package DI Number

20817583021346

Quantity per Package

1

Contains DI Package

10817583021349

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