| Primary Device ID | M695502C14852S0 |
| NIH Device Record Key | 481997fb-8871-413e-9ad4-a38c827012bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | MC2-C14852-S |
| Catalog Number | MC2-C14852-S |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| 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 | 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 | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M695502C14852S0 [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 | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-11-12 |