Duns Number:047775061
Device Description: PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains:1x Pre-drill, size PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains:1x Pre-drill, size 0.063" diameter x 4" length1x Pre-drill, size 0.078" diameter x 4" length1x Pre-drill, size 0.094" diameter x 4" length> For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565)Supplied Non-Sterile.
Catalog Number
400-3015
Brand Name
PONTiS Flexor Tendon Repar System
Version/Model Number
400-3015
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
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
337590e8-ff06-454b-a312-0f3290baaad9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |