| Primary Device ID | 00847538008661 |
| NIH Device Record Key | 8742df9a-8433-4d94-b8ca-9dc752ee80d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sigma Hip Revision Sleeve Extraction Case |
| Version Model Number | 84-1980 |
| Catalog Number | 2011-03-058 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847538008661 [Primary] |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
Moist Heat or Steam Sterilization
[00847538008661]
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 |
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| 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 |