| Primary Device ID | 28031497000644 |
| NIH Device Record Key | 1de85d60-d784-49af-aec6-c17da3d6d850 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InterSpace Hip |
| Version Model Number | SPC0322 |
| Company DUNS | 435428396 |
| Company Name | TECRES SPA |
| 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 |
| Length | 211 Millimeter |
| Device Size Text, specify | 0 |
| Length | 211 Millimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 28031497000644 [Primary] |
| MBB | Bone Cement, Antibiotic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-12 |
| 28031497000668 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |
| 28031497000651 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |
| 28031497000644 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |
| 28031497000637 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |
| 28031497000620 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |
| 28031497000613 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/poly |