| Primary Device ID | 00859210006070 |
| NIH Device Record Key | 93cd59fc-c656-45e8-9757-5007351a9220 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PONTiS Achilles Tendon Repair System |
| Version Model Number | 600-4001 |
| Catalog Number | 600-4001 |
| 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 | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com | |
| Phone | 415-567-8935 |
| info@pontisorthopaedics.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859210006070 [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 | 3 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2016-09-01 |
| 00859210006018 - PONTiS Flexor Tendon Repair System | 2020-02-06 PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilating catheter for tendon transfer |
| 08592110006100 - PONTiS Suture-Crimp Implant | 2019-05-07 PONTiS Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x #3-0 MFSS suture w |
| 00859210006001 - PONTiS Flexor Tendon Repair System | 2019-05-07 PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 |
| 00859210006032 - PONTiS Flexor Tendon Repair System | 2019-05-07 PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament |
| 00859210006070 - PONTiS Achilles Tendon Repair System | 2019-05-07PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 SS sutures Supplied pouched, sterilized with EO. |
| 00859210006070 - PONTiS Achilles Tendon Repair System | 2019-05-07 PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 |
| 00859210006117 - PONTiS Suture-Crimp Implant | 2019-05-07 PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x Dual #3-0 MFS |
| 00859210006025 - PONTiS Flexor Tendon Repair System | 2019-03-21 PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has si |
| 00859210006049 - PONTiS Flexor Tendon Repar System | 2018-03-29 PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre- |