Duns Number:131747628
Device Description: JumpStart, 12" X 12", Single Layer
Catalog Number
R1212-01
Brand Name
Arthrex®
Version/Model Number
R1212-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 07, 2021
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
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
aff1c22f-b9e7-41b0-bcc9-fe957fac8408
Public Version Date
May 11, 2021
Public Version Number
6
DI Record Publish Date
February 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |