| Primary Device ID | 00880304591585 |
| NIH Device Record Key | 1b2cbe6d-fb8b-400c-b299-addb2690de26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX DELTA HIP SYSTEM |
| Version Model Number | 12-115109 |
| Catalog Number | 12-115109 |
| 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 |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
| 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 | 00880304591585 [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 | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2015-10-24 |
| 00880304591639 | 12-115123 |
| 00880304591622 | 12-115122 |
| 00880304591615 | 12-115121 |
| 00880304591608 | 12-115120 |
| 00880304591585 | 12-115109 |
| 00880304521957 | 650-1057 |
| 00880304521933 | 650-1058 |
| 00880304521896 | 650-1056 |
| 00880304510562 | 650-1059 |
| 00880304448827 | 12-115110 |
| 00880304438804 | 12-115115 |
| 00880304438538 | 12-115116 |
| 00880304438392 | 12-115117 |
| 00880304437548 | 12-115111 |
| 00880304434035 | 12-115114 |
| 05019279316182 | 12-115134 |
| 05019279316175 | 12-115133 |
| 05019279316168 | 12-115132 |
| 05019279316151 | 12-115131 |
| 05019279316144 | 12-115130 |