| Primary Device ID | B707125341160 |
| NIH Device Record Key | d3846e57-580b-45e9-8741-5b49df4c3381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DualX Graft Nozzle Clearing Tool |
| Version Model Number | 12534116 |
| Company DUNS | 081021000 |
| Company Name | AMPLIFY SURGICAL, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B707125341160 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
[B707125341160]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| B707125342180 - DUALX ACME PIN | 2024-09-11 DUALX ACME PIN |
| B707128440050 - DualXS Implant Retainer Shaft | 2024-09-11 DUALXS IMPLANT RETAINER SHAFT |
| B707128450000 - DualXS Inserter Outer Shaft | 2024-09-11 DUALXS INSERTER OUTER SHAFT ASSEMBLY |
| B707128450010 - DualXS Fixed ACME Drawbar | 2024-09-11 DualXS Fixed ACME Drawbar |
| B707128450020 - DualXS Inserter Handle Acme | 2024-09-11 DualXS Inserter Handle Acme |
| B707129410010040 - DUALXS T/PLIF 8 DEG x 7-9MM | 2024-06-28 Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): |
| B707129410010050 - DUALXS T/PLIF 12 DEG x 7-10MM | 2024-06-28 Lordosis & Heights: 8° x 7-10mm Collapsed Width (mm): 12 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): |
| B707129410010120 - DUALXS T/PLIF 15 DEG x 8-11MM | 2024-06-28 Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 8 Expanded Height (mm) |