| Primary Device ID | 00849777012188 |
| NIH Device Record Key | 1b707ffa-fff9-4a77-b373-b4ee59707438 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isto Plus Flow 2.5cc - Syringe |
| Version Model Number | ISTO-FW-02 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849777012188 [Primary] |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-18 |
| Device Publish Date | 2022-11-10 |
| 00840311233007 - CONTACT ALP Anterior Lumbar Plate System | 2026-03-19 Temporary Holding Pin, Push Style, Lumbar / Sacral Plate |
| 00840311233014 - CONTACT ALP Anterior Lumbar Plate System | 2026-03-19 Temporary Holding Pin, Push Style, 25MM, Lumbar / Sacral Plate |
| M697X00310040 - Calix-C Cervical Interbody Spacer | 2026-03-18 Lordotic Caddy, Calix Cervical |
| M697X03422130 - Calix Lumbar Spinal Implant System | 2026-03-18 Calix-T Implant Caddy |
| 00840311262694 - CASE, OUTER, DOUBLE LEVEL | 2026-02-19 CASE, OUTER, DOUBLE LEVEL |
| 00840311262700 - CASE, OUTER, LID | 2026-02-19 CASE, OUTER, LID |
| 00840311247318 - Fortilink | 2026-01-30 TiPlus-TC Inserter, Straight |
| 00840311262670 - Cortera Spinal Fixation System | 2025-12-30 Caddy, Set Screw, 5.5-6.0 |