| Primary Device ID | B707125341100 |
| NIH Device Record Key | 45d397df-7f7f-4c42-b6d9-3d4aecdb1b06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dualX T-HANDLE |
| Version Model Number | 12534110 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B707125341100 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
[B707125341100]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-04 |
| Device Publish Date | 2020-07-27 |
| B707125341050 | Dual X T-Handle |
| B707125341100 | Dual X T-Handle |