Duns Number:131747628
Device Description: JumpStart, 4.5" x 10", Helix Comp. Layer
Catalog Number
HR4510-05
Brand Name
Arthrex®
Version/Model Number
HR4510-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
d254d74d-84e4-4a9d-b1be-6b2d53a45aea
Public Version Date
June 21, 2021
Public Version Number
7
DI Record Publish Date
February 15, 2017
Package DI Number
10888867186979
Quantity per Package
5
Contains DI Package
00888867186972
Package Discontinue Date
June 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |