Primary Device ID | 00811954013424 |
NIH Device Record Key | b8fc778b-e7c3-4e58-aa11-ade11ad15f53 |
Commercial Distribution Discontinuation | 2016-12-23 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | 8 Degree Lordotic, Opticage Expandable Interbody Implant |
Version Model Number | 9101-19 |
Catalog Number | 9101-19 |
Company DUNS | 017663522 |
Company Name | INTERVENTIONAL SPINE, INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | 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 | 800-497-0484 |
www.cs@i-spineinc.com | |
Phone | 800-497-0484 |
www.cs@i-spineinc.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811954013424 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2016-05-25 |
00811954013462 | 22mm Width x 55mm Length by 11mm-16mm Footprint Length |
00811954013455 | 22mm Width x 50mm Length by 11mm-16mm Footprint Length |
00811954013431 | 22mm Width x 40mm Length by 11mm-16mm Footprint Length |
00811954013424 | 18mm Width x 55mm Length by 11mm-16mm Footprint Length |
00811954013417 | 18mm Width x 50mm Length by 11mm-16mm Footprint Length |
00811954013400 | 18mm Width x 45mm Length by 11mm-16mm Footprint Length |
00811954013394 | 18mm Width x 40mm Length by 11mm-16mm Footprint Length |
00811954013387 | 16mm Width x 55mm Length by 11mm-16mm Footprint Length |
00811954013370 | 16mm Width x 50mm Length by 11mm-16mm Footprint Length |
00811954013363 | 16mm Width x 45mm Length by 11mm-16mm Footprint Length |
00811954013356 | 16mm Width x 40mm Length by 11mm-16mm Footprint Length |
00811954013349 | 12mm Width x 30mm Length by 11mm-16mm Footprint Length |
00811954013332 | 12mm Width x 26mm Length by 11mm-16mm Footprint Length |
00811954013325 | 12mm Width x 21mm Length by 11mm-16mm Footprint Length |
00811954013318 | 11mm Width x 30mm Length by 11mm-16mm Footprint Length |
00811954013301 | 11mm Width x 26mm Length by 11mm-16mm Footprint Length |
00811954013295 | 11mm Width x 21mm Length by 11mm-16mm Footprint Length |
00811954013288 | 10mm Width x 30mm Length by 11mm-16mm Footprint Length |
00811954013271 | 10mm Width x 26mm Length by 11mm-16mm Footprint Length |
00811954013264 | 10mm Width x 21mm Length by 11mm-16mm Footprint Length |
00811954013257 | 9mm Width x 30mm Length by 11mm-16mm Footprint Length |
00811954013240 | 9mm Width x 26mm Length by 11mm-16mm Footprint Length |
00811954013233 | 9mm Width x 21mm Length by 11mm-16mm Footprint Length |
00011954013448 | 22mm Width x 45mm Length by 11mm-16mm Footprint Length |