| Primary Device ID | 10889981207106 |
| NIH Device Record Key | 1a57d633-89e5-49f8-931c-69ca78778e95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reef TH |
| Version Model Number | TH2-001101 |
| Catalog Number | TH2-001101 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981207106 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
[10889981207106]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-28 |
| Device Publish Date | 2020-07-20 |
| 10889981217334 | TH Instrument Level 2 |
| 10889981217327 | TH Instrument Level 1 |
| 10889981217310 | Tray Case, Double Level |
| 10889981212940 | Trial 9w, 18mm |
| 10889981212933 | Trial 9w, 17mm |
| 10889981212926 | Trial 9w, 16mm |
| 10889981212919 | Trial 9w, 15mm |
| 10889981212902 | Trial 9w, 14mm |
| 10889981212896 | Trial 9w, 13mm |
| 10889981212889 | Trial 9w, 12mm |
| 10889981212872 | Trial 9w, 11mm |
| 10889981212865 | Trial 9w, 10mm |
| 10889981212858 | Trial 9w, 9mm |
| 10889981212841 | Trial 9w, 8mm |
| 10889981212834 | Trial 11w, 18mm |
| 10889981212827 | Trial 11w, 17mm |
| 10889981212810 | Trial 11w, 16mm |
| 10889981212803 | Trial 11w, 15mm |
| 10889981212797 | Trial 11w, 14mm |
| 10889981212780 | Trial 11w, 13mm |
| 10889981212773 | Trial 11w, 12mm |
| 10889981212766 | Trial 11w, 11mm |
| 10889981212759 | Trial 11w, 10mm |
| 10889981212742 | Trial 11w, 9mm |
| 10889981212735 | Trial 11w, 8mm |
| 10889981207106 | Notched Tamp |
| 10889981207090 | Inserter, 9w |
| 10889981203580 | Interbody, 9mm x 40mm x 18mm, 8 deg |
| 10889981203573 | Interbody, 9mm x 40mm x 18mm, 15 deg |
| 10889981203566 | Interbody, 9mm x 40mm x 18mm, 20 deg |
| 10889981203559 | Interbody, 9mm x 40mm x 18mm, 0 deg |
| 10889981203542 | Interbody, 9mm x 40mm x 17mm, 8 deg |
| 10889981203535 | Interbody, 9mm x 40mm x 17mm, 15 deg |
| 10889981203528 | Interbody, 9mm x 40mm x 17mm, 20 deg |
| 10889981203511 | Interbody, 9mm x 40mm x 17mm, 0 deg |
| 10889981203504 | Interbody, 9mm x 40mm x 16mm, 8 deg |
| 10889981203498 | Interbody, 9mm x 40mm x 16mm, 15 deg |
| 10889981203481 | Interbody, 9mm x 40mm x 16mm, 20 deg |
| 10889981203474 | Interbody, 9mm x 40mm x 16mm, 0 deg |
| 10889981203467 | Interbody, 9mm x 40mm x 15mm, 8 deg |
| 10889981203450 | Interbody, 9mm x 40mm x 15mm, 15 deg |
| 10889981203443 | Interbody, 9mm x 40mm x 15mm, 20 deg |
| 10889981203436 | Interbody, 9mm x 40mm x 15mm, 0 deg |
| 10889981203429 | Interbody, 9mm x 40mm x 14mm, 8 deg |
| 10889981203412 | Interbody, 9mm x 40mm x 14mm, 15 deg |
| 10889981203405 | Interbody, 9mm x 40mm x 14mm, 20 deg |
| 10889981203399 | Interbody, 9mm x 40mm x 14mm, 0 deg |
| 10889981203382 | Interbody, 9mm x 40mm x 13mm, 8 deg |
| 10889981203375 | Interbody, 9mm x 40mm x 13mm, 15 deg |
| 10889981203368 | Interbody, 9mm x 40mm x 13mm, 20 deg |