Disposable Tattoo Arm Sleeve Cover Barrier - Disposable Tattoo Arm Sleeve Cover Barrier, Poly, - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal

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More Product Details

Catalog Number

-

Brand Name

Disposable Tattoo Arm Sleeve Cover Barrier

Version/Model Number

2137

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

8e020a52-c256-4eb2-84f8-f8dab200de36

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

June 21, 2021

Additional Identifiers

Package DI Number

00616784213736

Quantity per Package

5

Contains DI Package

00616784213729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2