Primary Device ID | 00817329024477 |
NIH Device Record Key | 5026ccf8-8e17-4b44-a3e9-41c7a2747503 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FacetLINK MI |
Version Model Number | 80-2502 |
Catalog Number | 80-2502 |
Company DUNS | 067584601 |
Company Name | LINKSPINE, 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 | 1-410-772-5465 |
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 | 00817329024477 [Primary] |
MRW | System, Facet Screw Spinal Device |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00817329024477]
Moist Heat or Steam Sterilization
[00817329024477]
Moist Heat or Steam Sterilization
[00817329024477]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-11-27 |
Device Publish Date | 2018-05-08 |
00817329025658 | FacetLINK MI Set |
00817329024927 | FacetLINK MI Tray |
00817329024606 | Facet Screw Driver Outer Tube |
00817329024576 | Jamshidi Needle |
00817329024569 | Cannulated Torque Handle |
00817329024552 | Reamer |
00817329024545 | Drill Stop |
00817329024538 | Drill |
00817329024521 | Facet Screw Screwdriver |
00817329024514 | Trocar Stylet |
00817329024507 | Trocar Stylet |
00817329024491 | Dilator Handle |
00817329024484 | Dilator 3 |
00817329024477 | Dilator 2 |
00817329024460 | Dilator 1 |