| Primary Device ID | 03662663281638 |
| NIH Device Record Key | fdf554c9-a686-430f-8509-e0cb02631385 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breckenridge ACDF System |
| Version Model Number | 8843-1715 |
| Catalog Number | 8843-1715 |
| Company DUNS | 119260394 |
| Company Name | Highridge Medical, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663281638 [Primary] |
| HTR | RASP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663281638]
Moist Heat or Steam Sterilization
[03662663281638]
Moist Heat or Steam Sterilization
[03662663281638]
Moist Heat or Steam Sterilization
[03662663281638]
Moist Heat or Steam Sterilization
[03662663281638]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-24 |
| Device Publish Date | 2025-11-16 |
| 03662663281720 | HANDLE RADEL LONG |
| 03662663281713 | HANDLE RADEL ASSY |
| 03662663281690 | RASP 5DEG 2MM STOP 14X18X 9-10MM |
| 03662663281683 | RASP 5DEG 2MM STOP 14X18X 7-8MM |
| 03662663281676 | RASP 5DEG 2MM STOP 14X18X 5-6MM |
| 03662663281669 | RASP 5DEG 2MM STOP 14X18X 11-12MM |
| 03662663281652 | RASP 5DEG 1MM STOP 14X18X 9-10MM |
| 03662663281645 | RASP 5DEG 1MM STOP 14X18X 7-8MM |
| 03662663281638 | RASP 5DEG 1MM STOP 14X18X 5-6MM |
| 03662663281621 | RASP 5DEG 1MM STOP 14X18X 11-12MM |
| 03662663281614 | RASP 5DEG 0MM STOP 14X18X 9-10MM |
| 03662663281607 | RASP 5DEG 1MM STOP 13X16X 7-8MM |
| 03662663281591 | RASP 5DEG 1MM STOP 13X16X 5-6MM |
| 03662663281584 | RASP 5DEG 1MM STOP 13X16X 11-12MM |
| 03662663281577 | RASP 5DEG 0MM STOP 13X16X 9-10MM |
| 03662663281560 | RASP 5DEG 0MM STOP 13X16X 7-8MM |
| 03662663281553 | RASP 5DEG 0MM STOP 13X16X 5-6MM |
| 03662663281546 | RASP 5DEG 0MM STOP 13X16X 11-12MM |
| 03662663281539 | RASP 0DEG 11X14X8-9MM |
| 03662663281522 | RASP 0DEG 11X14X6-7MM |
| 03662663281515 | RASP ACDF 0DEG 12X14X12MM |
| 03662663281508 | RASP ACDF 0DEG 12X14X11MM |
| 03662663281492 | RASP ACDF 0DEG 12X14X10MM |
| 03662663281485 | RASP ACDF 0DEG 12X14X9MM |
| 03662663281478 | RASP ACDF 0DEG 12X14X8MM |
| 03662663281461 | RASP ACDF 0DEG 12X14X7MM |
| 03662663281454 | RASP ACDF 0DEG 12X14X6MM |
| 03662663281447 | RASP ACDF 0DEG 12X14X5MM |
| 03662663281430 | TRIAL ACDF 5DEG 2MM STOP 14X18X9-10MM |
| 03662663281423 | TRIAL ACDF 5DEG 2MM STOP 14X18X7-8MM |
| 03662663281416 | TRIAL ACDF 5DEG 2MM STOP 14X18X5-6MM |
| 03662663281409 | TRIAL ACDF 5DEG 2MM STOP 14X18X11-12MM |
| 03662663281393 | TRIAL ACDF 5DEG 1MM STOP 14X18X9-10MM |
| 03662663281386 | TRIAL ACDF 5DEG 1MM STOP 14X18X7-8MM |
| 03662663281379 | TRIAL ACDF 5DEG 1MM STOP 14X18X5-6MM |
| 03662663281362 | TRIAL ACDF 5DEG 1MM STOP 14X18X11-12MM |
| 03662663281355 | TRIAL ACDF 5DEG 0MM STOP 14X18X9-10MM |
| 03662663281348 | TRIAL ACDF 5DEG 0MM STOP 14X18X7-8MM |
| 03662663281331 | TRIAL ACDF 5DEG 0MM STOP 14X18X5-6MM |
| 03662663281324 | TRIAL ACDF 5DEG 0MM STOP 14X18X11-12MM |
| 03662663281317 | TRIAL ACDF 2MM STOP 5° 13X16X 5-6MM |
| 03662663281300 | TRIAL ACDF 2MM STOP 5° 13X16X 5-6MM |
| 03662663281294 | TRIAL ACDF 2MM STOP 5° 13X16X 5-6MM |
| 03662663281287 | TRIAL ACDF 2MM STOP 5° 13X16X 5-6MM |
| 03662663281270 | TRIAL ACDF 1MM STOP 5DEG 13X16X 9-11MM |
| 03662663281263 | TRIAL ACDF 1MM STOP 5DEG 13X16X 7-8MM |
| 03662663281256 | TRIAL ACDF 1MM STOP 5DEG 13X16X 5-6MM |
| 03662663281249 | TRIAL ACDF 1MM STOP 5DEG 13X16X 11-12MM |
| 03662663281232 | TRIAL ACDF 0MM STOP 5DEG 13X16X 9-10MM |
| 03662663281225 | TRIAL ACDF 0MM STOP 5DEG 13X16X 7-8MM |