Duns Number:942377524
Device Description: Integra® Silicone PIPStarter AwlThe Starter Awl is used to penetrate the articular surface Integra® Silicone PIPStarter AwlThe Starter Awl is used to penetrate the articular surface and expose the canal of the metacarpal and phalangeal bone.
Catalog Number
AWL-520-01
Brand Name
Integra®
Version/Model Number
AWL-520-01
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
-
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
-
Product Code
HWJ
Product Code Name
AWL
Public Device Record Key
fd022154-dcb2-4fcc-a0c9-b0f2568a77df
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |