| Primary Device ID | 18257200064328 |
| NIH Device Record Key | cce5fba4-e77d-46ca-b96e-beca4a380822 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASCENT LE |
| Version Model Number | 66-3246 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX 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 | true |
| 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 |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200064328 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
[18257200064328]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
| 18257200125166 | LID, ASCENT LE CASE |
| 18257200082056 | EVOLUTION, REMOVAL KIT, THORACOLUMBAR SPINE HARDWARE (ES-0005) |
| 18257200081998 | ASCENT LE ML BIAS ANGLE SCREWS (66-0023) |
| 18257200081981 | ASCENT LE CC BIAS ANGLE SCREWS (66-0024) |
| 18257200081974 | ASCENT LE SMOOTH SHANK SCREWS (66-0022) |
| 18257200081967 | ASCENT LE MULTI-AXIAL SCREWS (66-0021) |
| 18257200081615 | ASCENT LE AUX (66-0030) |
| 18257200081608 | ASCENT LE IMPLANTS (66-0020) |
| 18257200081592 | ASCENT LE INST 2 (66-0011) |
| 18257200081585 | ASCENT LE INST 1 (66-0010) |
| 18257200064700 | 4.0MM X 52MM C-C BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064694 | 4.0MM X 50MM C-C BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064687 | 4.0MM X 48MM C-C BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064670 | 4.0MM X 46MM C-C BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064663 | 4.0MM X 44MM C-C BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064656 | 4.0MM X 36MM C-C BIASED ANGLE SCREW, ASCENT LE POCT |
| 18257200064649 | 3.5MM X 52MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064632 | 3.5MM X 50MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064625 | 3.5MM X 48MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064618 | 3.5MM X 46MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064601 | 3.5MM X 44MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064595 | 3.5MM X 42MM C-C BIASED ANGLE SCREW ASSY |
| 18257200064588 | 4.0MM X 52MM M-L BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064571 | 4.0MM X 50MM M-L BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064564 | 4.0MM X 48MM M-L BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064557 | 4.0MM X 46MM M-L BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064540 | 4.0MM X 44MM M-L BIASED ANGLE RESCUE SCREW ASSY |
| 18257200064533 | 3.5MM X 52MM M-L BIASED ANGLE SCREW |
| 18257200064526 | 3.5MM X 50MM M-L BIASED ANGLE SCREW |
| 18257200064519 | 3.5MM X 48MM M-L BIASED ANGLE SCREW |
| 18257200064502 | 3.5MM X 46MM M-L BIASED ANGLE SCREW |
| 18257200064496 | 3.5MM X 44MM M-L BIASED ANGLE SCREW |
| 18257200064489 | 3.5MM X 42MM M-L BIASED ANGLE SCREW |
| 18257200064472 | 4.0MM X 52MM MULTI-AXIAL SCREW ASSY |
| 18257200064465 | 4.0MM X 50MM MULTI-AXIAL SCREW ASSY |
| 18257200064458 | 4.0MM X 48MM MULTI-AXIAL SCREW ASSY |
| 18257200064441 | 4.0MM X 46MM MULTI-AXIAL SCREW ASSY |
| 18257200064434 | 4.0MM X 44MM MULTI-AXIAL SCREW ASSY |
| 18257200064427 | 4.0MM X 36MM MULTI-AXIAL SCREW, ASCENT LE POCT |
| 18257200064410 | 3.5MM X 52MM MULTI-AXIAL SCREW ASSY |
| 18257200064403 | 3.5MM X 50MM MULTI-AXIAL SCREW ASSY |
| 18257200064397 | 3.5MM X 48MM MULTI-AXIAL SCREW ASSY |
| 18257200064380 | 3.5MM X 46MM MULTI-AXIAL SCREW ASSY |
| 18257200064373 | 3.5MM X 44MM MULTI-AXIAL SCREW ASSY |
| 18257200064366 | 3.5MM X 42MM MULTI-AXIAL SCREW ASSY |
| 18257200064359 | 4.0MM X 52MM SMOOTH SHANK SCREW ASSY |
| 18257200064342 | 4.0MM X 50MM SMOOTH SHANK SCREW ASSY |
| 18257200064335 | 4.0MM X 48MM SMOOTH SHANK SCREW ASSY |
| 18257200064328 | 4.0MM X 46MM SMOOTH SHANK SCREW ASSY |
| 18257200064311 | 4.0MM X 44MM SMOOTH SHANK SCREW ASSY |