| Primary Device ID | 00847538001235 |
| NIH Device Record Key | 9d78ea9e-6934-46e5-b793-9dbf12a58ee3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | “X” Osteotome, 7mm |
| Version Model Number | 10-008-000 |
| Catalog Number | 00-9986-010-17;00-9986-010-17 |
| Company DUNS | 079881212 |
| Company Name | SYMMETRY MEDICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847538001235 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00847538001235]
Moist Heat or Steam Sterilization
[00847538001235]
Moist Heat or Steam Sterilization
[00847538001235]
Moist Heat or Steam Sterilization
[00847538001235]
Moist Heat or Steam Sterilization
[00847538001235]
Moist Heat or Steam Sterilization
[00847538001235]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-20 |
| Device Publish Date | 2022-05-12 |
| 00847538006360 | “X” Osteotome, 7mm |
| 00847538001235 | “X” Osteotome, 7mm |