| Primary Device ID | 00887517388612 |
| NIH Device Record Key | 0d4e5e3e-24f8-4f5a-ade1-6c92dbf8ad3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR |
| Version Model Number | 6902044 |
| Company DUNS | 053950783 |
| Company Name | Nuvasive, 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 |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517388612 [Primary] |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887517388612]
Moist Heat or Steam Sterilization
[00887517388612]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-09-17 |
| 00887517391759 | XLR Trial, 20x38x28 15° Detachable |
| 00887517391742 | XLR Trial, 18x38x28 15° Detachable |
| 00887517391735 | XLR Trial, 16x38x28 15° Detachable |
| 00887517391728 | XLR Trial, 14x38x28 15° Detachable |
| 00887517391711 | XLR Trial, 12x38x28 15° Detachable |
| 00887517388629 | XLR Trial, 20x38x28 8° Detachable |
| 00887517388612 | XLR Trial, 20x34x24 8° Detachable |
| 00887517388261 | XLR Trial, 18x38x28 8° Detachable |
| 00887517388254 | XLR Trial, 18x34x24 8° Detachable |
| 00887517388247 | XLR Trial, 16x38x28 8° Detachable |
| 00887517388230 | XLR Trial, 16x34x24 8° Detachable |
| 00887517387820 | XLR Trial, 14x38x28 8° Detachable |
| 00887517387813 | XLR Trial, 14x34x24 8° Detachable |
| 00887517387806 | XLR Trial, 12x38x28 8° Detachable |
| 00887517387493 | XLR Trial, 12x34x24 8° Detachable |
| 00887517387486 | XLR Trial, 10x38x28 8° Detachable |
| 00887517387479 | XLR Trial, 10x34x24 8° Detachable |
| 00887517384638 | XLR Distractor, Tang Bottom |
| 00887517384348 | XLR Rasp |
| 00887517383570 | XLR Tamp, Implant Oblique |
| 00887517383563 | XLR Tamp, Implant Straight |
| 00887517383532 | XLR Inserter, Implant |
| 00887517405739 | ALIF EnVoy Instrument Tray Base |