| Primary Device ID | 00855195006609 |
| NIH Device Record Key | 70bd0969-bb77-4d2f-91fa-dd72c56af1ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remedy Spectrum GV Spacer |
| Version Model Number | GVLSLG |
| Company DUNS | 079596704 |
| Company Name | OSTEOREMEDIES, LLC |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00855195006609 [Primary] |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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 | 2018-12-21 |
| Device Publish Date | 2018-11-20 |
| 00855195006609 | REMEDY SPECTRUM GV Femoral Long Stem LG |
| 00855195006593 | REMEDY SPECTRUM GV Femoral Long Stem MD |
| 00855195006586 | REMEDY SPECTRUM GV Femoral Long Stem SM |
| 00855195006579 | REMEDY SPECTRUM GV Femoral Stem LG |
| 00855195006562 | REMEDY SPECTRUM GV Femoral Stem MD |
| 00855195006555 | REMEDY SPECTRUM GV Femoral Stem SM |
| 00855195006548 | REMEDY SPECTRUM GV Femoral Head - 60mm |
| 00855195006531 | REMEDY SPECTRUM GV Femoral Head - 54mm |
| 00855195006524 | REMEDY SPECTRUM GV Femoral Head - 46mm |
| 00850011453063 | REMEDY SPECTRUM® GV Femoral Head - 40mm |