| Primary Device ID | 09348215053284 |
| NIH Device Record Key | 92dfc6c8-d668-4482-8b94-b95a4157f1f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remedy Hip Stem |
| Version Model Number | D111-19-0701 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348215053284 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-28 |
| Device Publish Date | 2022-09-20 |
| 09348215053338 | D111-19-1201 |
| 09348215053321 | D111-19-1101 |
| 09348215053314 | D111-19-1001 |
| 09348215053307 | D111-19-0901 |
| 09348215053291 | D111-19-0801 |
| 09348215053284 | D111-19-0701 |
| 09348215053277 | D111-19-0601 |
| 09348215053260 | D111-19-0501 |
| 09348215053253 | D111-19-0401 |
| 09348215053246 | D111-19-0301 |
| 09348215053239 | D111-19-0201 |
| 09348215053222 | D111-19-0101 |
| 09348215053215 | D111-19-0001 |
| 09348215053208 | D111-19-1200 |
| 09348215053192 | D111-19-1100 |
| 09348215053185 | D111-19-1000 |
| 09348215053178 | D111-19-0900 |
| 09348215053161 | D111-19-0800 |
| 09348215053154 | D111-19-0700 |
| 09348215053147 | D111-19-0600 |
| 09348215053130 | D111-19-0500 |
| 09348215053123 | D111-19-0400 |
| 09348215053116 | D111-19-0300 |
| 09348215053109 | D111-19-0200 |
| 09348215053093 | D111-19-0100 |
| 09348215053086 | D111-19-0000 |