Batrik SaveFace Disposable Shoe Covers\Dispenser box - SaveFace Shoe Covers, anti skid, universal size, - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: SaveFace Shoe Covers, anti skid, universal size, Blue

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More Product Details

Catalog Number

SF-SC02UV

Brand Name

Batrik SaveFace Disposable Shoe Covers\Dispenser box

Version/Model Number

SF-SC02UV

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"

Yes

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

42832e1a-8153-401c-9be8-0989ea963126

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BATRIK MEDICAL MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 748
2 A medical device with a moderate to high risk that requires special controls. 20