| Primary Device ID | 00817329023197 |
| NIH Device Record Key | 22d350a7-9f9a-4646-a884-a43462f92370 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VertebraLINK MI |
| Version Model Number | 84-0630 |
| Catalog Number | 84-0630 |
| Company DUNS | 067584601 |
| Company Name | LINKSPINE, INC. |
| 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 | 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 | 1-410-772-5465 |
| cs@linkspine.com | |
| Phone | 1-410-772-5465 |
| cs@linkspine.com | |
| Phone | 1-410-772-5465 |
| cs@linkspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817329023197 [Primary] |
| GDX | Scalpel, One-Piece |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817329023197]
Moist Heat or Steam Sterilization
[00817329023197]
Moist Heat or Steam Sterilization
[00817329023197]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-28 |
| Device Publish Date | 2018-05-29 |
| 00817329025672 | VertebraLINK MI Set |
| 00817329024590 | MI Inserter - 10mm |
| 00817329024583 | MI Inserter - 8mm |
| 00817329023203 | MI Inserter Draw Rod |
| 00817329023197 | Bayonetted Scalpel Handle |