| Primary Device ID | 00847538008630 | 
| NIH Device Record Key | 9f483ae5-289b-43ef-9be3-6bb771000c3b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Flex Osteotome Delivery System | 
| Version Model Number | 25-037-000 | 
| Catalog Number | 2709-04-100 | 
| 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 | 00847538008630 [Primary] | 
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
[00847538008630]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-05-25 | 
| Device Publish Date | 2022-05-17 | 
| 00847538009415 - Short Fin Osteotome Blade | 2024-07-08 Short Fin Osteotome Blade | 
| 00847538008654 - HP Extraction Standard Removal Case | 2023-12-06 HP Extraction Standard Removal Case | 
| 00847538009330 - Long Radial Osteotome Blade | 2023-10-31 Long Radial Osteotome Blade | 
| 00847538009293 - Short Radial Osteotome Blade | 2023-10-02 Short Radial Osteotome Blade | 
| 00847538009316 - Medium Radial Osteotome Blade | 2023-10-02 Medium Radial Osteotome Blade | 
| 00847538009354 - Long Flat Osteotome Blade | 2023-10-02 Long Flat Osteotome Blade | 
| 00847538009378 - Medium Flat Osteotome Blade | 2023-10-02 Medium Flat Osteotome Blade | 
| 00847538018721 - GLOBAL UNITE™ Short Stem Instrumentation | 2023-09-13 SHORT BULLET TIP REAMER 8MM |