| Primary Device ID | 10861445000300 |
| NIH Device Record Key | e8e54a3f-9cdb-4929-b474-b6be61952a6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoNextions TR Tendon Repair System-Combo Kit |
| Version Model Number | FA0001 |
| Catalog Number | FA0001 |
| Company DUNS | 063692935 |
| Company Name | CONEXTIONS MEDICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com | |
| Phone | (385) 351-1461 |
| customerservice@conextionsmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861445000303 [Primary] |
| GS1 | 10861445000300 [Package] Contains: 00861445000303 Package: 10-Pack [10 Units] In Commercial Distribution |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-06 |
| Device Publish Date | 2022-04-28 |
| 10861445000300 - CoNextions TR Tendon Repair System-Combo Kit | 2022-05-06The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement. |
| 10861445000300 - CoNextions TR Tendon Repair System-Combo Kit | 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc |
| 10861445000317 - CoNextions TR Tendon Repair System-Deployment Mechanism | 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc |
| 10861445000324 - CoNextions TR Tendon Repair System-Implant Mechanism | 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc |
| 10861445000331 - Coronet | 2020-07-08 The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to ti |