Duns Number:089055867
Device Description: SCREW 9001635 TIMESH SDS 1.6X3.5MM OPT 6
Catalog Number
-
Brand Name
TiMesh®
Version/Model Number
9001635
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K062348,K062348
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
72b2336e-fef5-40df-a98d-32e5ef09d55d
Public Version Date
February 09, 2021
Public Version Number
4
DI Record Publish Date
July 15, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |