| Primary Device ID | 00844505006668 |
| NIH Device Record Key | a023cf69-e7af-41df-8bc0-6c2e4ebb050a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GRACE BUCKET HANDLE OFFSET |
| Version Model Number | 430-600 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844505006668 [Primary] |
| ETB | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2016-02-18 |
| 00844505006668 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 6.00MM L TITANIUM/NITINOL HANDLE |
| 00844505006651 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 5.50MM L TITANIUM/NITINOL HANDLE |
| 00844505001724 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 5.00MM L TITANIUM/NITINOL HANDLE |
| 00844505001717 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.75MM L TITANIUM/NITINOL HANDLE |
| 00844505001700 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.50MM L TITANIUM/NITINOL HANDLE |
| 00844505001694 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.25MM L TITANIUM/NITINOL HANDLE |
| 00844505001687 | GRACE BUCKET HANDLE OFFSET 0.4MM DIA X 4.00MM L TITANIUM/NITINOL HANDLE |