Duns Number:001191048
Device Description: OptiFix AT Absorbable Fixation System with Articulating Technology – 15 absorbable fastene OptiFix AT Absorbable Fixation System with Articulating Technology – 15 absorbable fasteners
Catalog Number
0113315
Brand Name
OptiFix AT Absorbable Fixation System with Articulating Technology
Version/Model Number
0113315
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
-
Product Code
GDW
Product Code Name
Staple, implantable
Public Device Record Key
7b881889-8149-4bb8-853d-909e4ba56255
Public Version Date
July 26, 2019
Public Version Number
1
DI Record Publish Date
July 18, 2019
Package DI Number
10801741136556
Quantity per Package
5
Contains DI Package
00801741136559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |