| Primary Device ID | M69601IM550 |
| NIH Device Record Key | a5d68503-b28e-484a-9f8a-48f54572a4c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OIC Intramedullary Nail System |
| Version Model Number | 01-IM55 |
| Company DUNS | 070061160 |
| Company Name | ORTHOPAEDIC IMPLANT COMPANY, THE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M69601IM550 [Primary] |
| HSB | Rod, Fixation, Intramedullary And Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
[M69601IM550]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2017-02-01 |
| M69601IM480 | EXTRACTION BOLT |
| 10811998036554 | EXTRACTION BOLT, FEMUR |
| 10811998036462 | EXTRACTION BOLT |
| 10811998038084 | BALL TIP GUIDE ROD 3.0MM X 800MM (PACK OF 10) |
| 10811998038138 | 127.5 DEGREE HIP NAIL 10MM X 180MM |
| 10811998038121 | SET SCREW EXTRACTION TOOL, 4.5MM HEX |
| 10811998038114 | 4.0MM X 155MM RADIOLUCENT TWIST DRILL BIT |
| 10811998038107 | 127.5 DEGREE HIP NAIL 11MM X 440MM RIGHT |
| 10811998038091 | 127.5 DEGREE HIP NAIL 11MM X 440MM LEFT |
| M69601TIB010 | STERILIZATION CASE IM NAIL TIBIA TRAY |
| M69601IM550 | STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY |
| M69601IM540 | STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY |
| M69601IM000 | STERILIZATION CASE IM NAIL BASE TRAY |
| M69601ARFN0010 | STERILIZATION CASE IM NAIL ARFN TRAY |
| 10811998036585 | STERILIZATION CASE IM TIBIA NAILS |
| 10811998036578 | STERILIZATION CASE IM NAIL EXTRACTION SET TRAY |
| 10811998036530 | STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY |
| 10811998036523 | STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY |
| 10811998036011 | STERILIZATION CASE IM NAIL BASE TRAY |
| 10811998036004 | STERILIZATION CASE IM NAIL ARFN TRAY |
| 10811998038145 | 127.5 DEGREE HIP NAIL 10MM X 210MM |
| M69601IM520 | IM NAIL REDUCTION TOOL |
| M69601IM010 | T-HANDLE AWL |
| 10811998036509 | IM NAIL REDUCTION TOOL |
| 10811998036028 | T-HANDLE AWL |
| 10811998038169 | 10 mm x 600 mm FUSION NAIL, RIGHT |
| 10811998038152 | 10 mm x 600 mm FUSION NAIL, LEFT |
| M696GW031000S0 | BALL TIP GUIDE ROD 3.0MM X 1000MM |
| 10811998036851 | BALL TIP GUIDE ROD 3.0MM X 1000MM |
| 10811998036844 | BALL TIP GUIDE ROD 3.0MM X 1000MM |
| 10811998039937 | TIBIAL NAIL 10MM X 350MM |
| 10811998039920 | TIBIAL NAIL 10MM X 330MM |
| 10811998039913 | TIBIAL NAIL 9MM X 350MM |
| 10811998039906 | TIBIAL NAIL 9MM X 330MM |