Duns Number:109903521
Device Description: DYNOMITE 2.0 MM PEEK WITH 1 ULTRABRAID SUTURE SIZES 2-0 DYNOMITE 2.0 MM PEEK WITH 1 ULTRABRAID SUTURE SIZES 2-0 AND NEEDLES
Catalog Number
72201881
Brand Name
DYNOMITE
Version/Model Number
72201881
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
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
ca3d24b0-742e-4b56-a993-3303b6b6a97d
Public Version Date
October 22, 2020
Public Version Number
6
DI Record Publish Date
August 29, 2015
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 |