Arthrex® - 4" X 4" HELIX COMPOSITE LAYER - ARTHREX, INC.

Duns Number:131747628

Device Description: 4" X 4" HELIX COMPOSITE LAYER

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ABS-4053

Brand Name

Arthrex®

Version/Model Number

ABS-4053

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K130350,K130350

Product Code Details

Product Code

FRO

Product Code Name

Dressing, wound, drug

Device Record Status

Public Device Record Key

5236538a-27a7-4d11-b502-0c4a5b4b9835

Public Version Date

June 19, 2020

Public Version Number

8

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

10888867225357

Quantity per Package

5

Contains DI Package

00888867225350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARTHREX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6506
2 A medical device with a moderate to high risk that requires special controls. 3411
3 A medical device with high risk that requires premarket approval 1
U Unclassified 2