Duns Number:109903521
Device Description: TWINFIX 5.0 MM ABSORBABLE MATERIAL THREADED DILATOR, RE TWINFIX 5.0 MM ABSORBABLE MATERIAL THREADED DILATOR, REUSABLE
Catalog Number
7209946
Brand Name
TWINFIX
Version/Model Number
7209946
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
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
f972d667-5960-4a97-b30a-59f6f6be1788
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 27, 2016
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |