| Primary Device ID | 00844505000253 |
| NIH Device Record Key | 6aeef358-5a86-42ea-aeb2-4e884d683de3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOTAL TILT TOP HEAD OFFSET |
| Version Model Number | 202 |
| Company DUNS | 030849173 |
| Company Name | Grace Medical, 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 | 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)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 | 00844505000253 [Primary] |
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-18 |
| 00844505000307 | TOTAL TILT TOP 3.50MM HEAD OFFSET 1MM DIA X 8MM L HA/OTOSIL |
| 00844505000260 | TOTAL TILT TOP 4MM HEAD OFFSET 1MM DIA X 8MM L HA/OTOSIL |
| 00844505000253 | TOTAL TILT TOP 3.25MM HEAD OFFSET 1MM DIA X 8MM L HA/OTOSIL |