| Primary Device ID | 00880304449336 |
| NIH Device Record Key | 59aa45c8-5f57-498e-a1f5-0de97dff8ed7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REGENEREX HIP SYSTEM |
| Version Model Number | PT-124858 |
| Catalog Number | PT-124858 |
| 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 | |
| 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 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 | 00880304449336 [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 |
| 00880304453807 | PT-124252 |
| 00880304450257 | PT-210152 |
| 00880304450240 | PT-210154 |
| 00880304450233 | PT-210358 |
| 00880304450226 | PT-210156 |
| 00880304450219 | PT-210352 |
| 00880304450202 | PT-210354 |
| 00880304450196 | PT-210258 |
| 00880304450189 | PT-210256 |
| 00880304450172 | PT-210356 |
| 00880304450165 | PT-210252 |
| 00880304450158 | PT-210158 |
| 00880304450141 | PT-210254 |
| 00880304449350 | PT-126474 |
| 00880304449343 | PT-125060 |
| 00880304449336 | PT-124858 |
| 00880304449329 | PT-124454 |
| 00880304449312 | PT-125262 |
| 00880304449305 | PT-124656 |
| 00880304449299 | PT-125464 |
| 00880304449282 | PT-126676 |
| 00880304449275 | PT-125666 |
| 00880304449268 | PT-126070 |
| 00880304449251 | PT-126272 |
| 00880304449244 | PT-125868 |