| Primary Device ID | 00849777011938 |
| NIH Device Record Key | c7826aa9-aec8-48cd-b00b-5aa57f850064 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Influx Plus Crunch 10.0cc - Syringe |
| Version Model Number | IFLX-CR-10 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849777011938 [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 | 2021-09-02 |
| Device Publish Date | 2021-08-25 |
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| M697C02200201 - Fortex Pedicle Screw System | 2023-04-06 5.5mm Special Single Lead Tap |
| M697C02200211 - Fortex Pedicle Screw System | 2023-04-06 6.5mm Special Single Lead Tap |