| Primary Device ID | B707128440090 |
| NIH Device Record Key | b0f05883-0fe9-40aa-99ac-2cc29ecde1cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALXS ACME INSERTER HANDLE ACME |
| Version Model Number | 12844009 |
| 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 | B707128440090 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
[B707128440090]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-30 |
| Device Publish Date | 2025-04-22 |
| B707125355740300 - DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA) | 2026-03-13 INCLUDES: CANNULA 30MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740400 - DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA) | 2026-03-13 INCLUDES: CANNULA 40MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740500 - DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA) | 2026-03-13 INCLUDES: CANNULA 50MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740600 - DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA) | 2026-03-13 INCLUDES: CANNULA 60MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740700 - DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA) | 2026-03-13 INCLUDES: CANNULA 70MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740800 - DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA) | 2026-03-13 INCLUDES: CANNULA 80MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740900 - DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA) | 2026-03-13 INCLUDES: CANNULA 90MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355741000 - DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA) | 2026-03-13 INCLUDES: CANNULA 100MM HEMOSTATIC AGENT DELIVERY TUBE |