| Primary Device ID | 00887517055637 |
| NIH Device Record Key | 0e5d48e6-5144-4611-834b-09090f11b546 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 2010770 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00887517055637 [Primary] |
| BSK | Cuff, tracheal tube, inflatable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
| 00195377000040 - ACP | 2025-05-30 ACP DTS Guide, Mid 0° |
| 00195377000200 - Cohere | 2025-05-30 COHERE Pivoting Trial, 15x11x34mm 15° |
| 00195377000217 - Cohere | 2025-05-30 COHERE Pivoting Trial, 14x14x34mm 8° |
| 00195377000224 - Cohere | 2025-05-30 COHERE Pivoting Trial, 14x14x30mm 8° |
| 00195377000231 - Cohere | 2025-05-30 COHERE Pivoting Trial, 14x11x34mm 15° |
| 00195377000248 - Cohere | 2025-05-30 COHERE Pivoting Trial, 13x9x30mm 15° |
| 00195377000255 - Cohere | 2025-05-30 COHERE Pivoting Trial, 13x14x30mm 8° |
| 00195377000262 - Cohere | 2025-05-30 COHERE Pivoting Trial, 13x11x34mm 15° |