Duns Number:001191048
Device Description: OptiFix Open Absorbable Fixation System
Catalog Number
0113320
Brand Name
OptiFix Open Absorbable Fixation System
Version/Model Number
0113320
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
898b5066-53d3-47bd-8f67-a8d52f6e6fc7
Public Version Date
January 08, 2019
Public Version Number
3
DI Record Publish Date
January 10, 2018
Package DI Number
10801741128957
Quantity per Package
5
Contains DI Package
00801741128950
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |