| Primary Device ID | 09348215040796 |
| NIH Device Record Key | 22c1741a-8f1b-4234-b113-45e455857b70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stem Impactor |
| Version Model Number | 112-28-0029 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
| 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 | false |
| 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 | 09348215040796 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
[09348215040796]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2018-10-09 |
| 09348215076726 | 112-25-0160 |
| 09348215040796 | 112-28-0029 |