Duns Number:047775061
Device Description: PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader KitEach Kit contains:1x D PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader KitEach Kit contains:1x Dilating catheter for tendon transfer and pulley dilation1x Funnel for tendon transfer1x SS threader for threading sutures through the catheter & funnelSupplied pouched, sterilized with EO.
Catalog Number
400-3014
Brand Name
PONTiS Flexor Tendon Repair System
Version/Model Number
400-3014
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
K081060
Product Code
GAQ
Product Code Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Public Device Record Key
3a867bfe-fdc7-49ad-a8e6-79bb70e28476
Public Version Date
December 04, 2020
Public Version Number
6
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 |