Duns Number:001191048
Device Description: SorbaFix Absorbable Fixation System 15 Absorbable Fasteners
Catalog Number
0113115
Brand Name
SorbaFix Absorbable Fixation System
Version/Model Number
0113115
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
a2614598-9cdd-48f5-a009-64eea73d4433
Public Version Date
January 08, 2019
Public Version Number
3
DI Record Publish Date
May 20, 2015
Package DI Number
10801741016698
Quantity per Package
5
Contains DI Package
00801741016691
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 |