Duns Number:079471560
Device Description: 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) Sterile Single Use
Catalog Number
DFX0035A
Brand Name
PunchTac 5.5mm Anchor PEEK
Version/Model Number
DFX0035A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K160996,K160996
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
8d9d2c79-2dac-41a0-a6b5-9b898282c90d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 12, 2017
Package DI Number
00854629006260
Quantity per Package
5
Contains DI Package
00854629006253
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |