Duns Number:001191048
Device Description: PermaFix Fixation System 15 Fasteners
Catalog Number
0113119
Brand Name
PermaFix Fixation System
Version/Model Number
0113119
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
2649f4ee-6434-4b75-9cc6-752625fc30d4
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
May 20, 2015
Package DI Number
10801741016711
Quantity per Package
5
Contains DI Package
00801741016714
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 |