| Primary Device ID | 00859210006025 |
| NIH Device Record Key | 8e342132-b741-4037-aad3-af0e366c7ece |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PONTiS Flexor Tendon Repair System |
| Version Model Number | 400-3031 |
| Catalog Number | 400-3031 |
| Company DUNS | 047775061 |
| Company Name | PONTIS ORTHOPAEDICS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com |
| Outer Diameter | 3 Millimeter |
| Outer Diameter | 3 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859210006025 [Primary] |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-09-01 |
| 00859210006032 | PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use wit |
| 00859210006025 | PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor |
| 00859210006018 | PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilat |
| 00859210006001 | PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. |