| Primary Device ID | 00844505013260 |
| NIH Device Record Key | b681879c-1d9a-4fc8-87cb-1e8334e34969 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALTO TOTAL |
| Version Model Number | 600-M2 |
| Company DUNS | 030849173 |
| Company Name | Grace Medical, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844505013260 [Primary] |
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-16 |
| Device Publish Date | 2021-02-08 |
| 00844505002073 | OFFSET ALTO TOTAL 0.56MM DIA SHOE TITANIUM/SILICONE |
| 00844505013260 | OFFSET ALTO TOTAL 0.56MM DIA SHOE SIZERS INCLUDED TITANIUM/SILICONE |