| Primary Device ID | 00814216024688 |
| NIH Device Record Key | aac1c7fc-f0b0-4529-86a1-4badc083bc8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoAccessTM |
| Version Model Number | 21502-3413 |
| Catalog Number | 21502-3413 |
| Company DUNS | 079898044 |
| Company Name | NANOVIS SPINE, LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com | |
| Phone | 8779076266 |
| nanovisquality@nanovistechnology.com |
| Width | 13 Millimeter |
| Width | 13 Millimeter |
| Width | 13 Millimeter |
| Width | 13 Millimeter |
| Width | 13 Millimeter |
| Width | 13 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814216024688 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00814216024688]
Moist Heat or Steam Sterilization
[00814216024688]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2017-11-07 |
| 00814216024688 | OrthoAccessTM 13x34x13x6° TLIF G2 Implant |
| 00814216021304 | OrthoAccessTM 13x34x12x6° TLIF G2 Implant |
| 00814216021298 | OrthoAccessTM 13x34x11x6° TLIF G2 Implant |
| 00814216021281 | OrthoAccessTM 13x34x10x6° TLIF G2 Implant |
| 00814216021274 | OrthoAccessTM 13x34x9x6° TLIF G2 Implant |