Arthrex® - JumpStart, 4" X 4", Helix Comp. Layer - ARTHREX, INC.

Duns Number:131747628

Device Description: JumpStart, 4" X 4", Helix Comp. Layer

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More Product Details

Catalog Number

HR0404-05

Brand Name

Arthrex®

Version/Model Number

HR0404-05

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

7998b749-ca16-4f12-a326-31928caa5925

Public Version Date

June 21, 2021

Public Version Number

7

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

10888867186597

Quantity per Package

5

Contains DI Package

00888867186590

Package Discontinue Date

June 19, 2021

Package Status

Not 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