| Primary Device ID | 00880304253131 |
| NIH Device Record Key | efc19fa1-620b-4be1-a4d1-6ad53138a3d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANSWER / IMPACT / INTEGRAL HIP SYSTEM |
| Version Model Number | 162646 |
| Catalog Number | 162646 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, 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 | false |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304253131 [Primary] |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| 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 | 2015-10-24 |
| 00880304253223 | 162661 |
| 00880304253216 | 162660 |
| 00880304253162 | 162656 |
| 00880304253131 | 162646 |
| 00880304253124 | 162644 |
| 00880304253117 | 162643 |
| 00880304253100 | 162642 |
| 00880304253094 | 162641 |
| 00880304253087 | 162640 |
| 00880304009189 | 162659 |
| 00880304005792 | 162657 |
| 00880304001169 | 162658 |