Duns Number:047775061
Device Description: PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains:1x SS Crimp Collar for use PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains:1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures.Supplied pouched, sterilized with EO.
Catalog Number
401-3006
Brand Name
PONTiS Flexor Tendon Repair System
Version/Model Number
401-3006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
8277592a-2da5-4f7b-99c3-18532c572e1d
Public Version Date
February 05, 2021
Public Version Number
5
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 |