Regenerex® Ringloc®+ Hip System PT-104050
GUDID 00887868341755
Biomet Orthopedics, LLC
Acetabular shell| Primary Device ID | 00887868341755 |
| NIH Device Record Key | d12c51bd-aef7-40d4-86f5-c39b90ceeb4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regenerex® Ringloc®+ Hip System |
| Version Model Number | PT-104050 |
| Catalog Number | PT-104050 |
| 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 |
Customer Support Contacts
| 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 Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868341755 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070369
FDA Product Code
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-26 |
| Device Publish Date | 2019-04-18 |
On-Brand Devices [Regenerex® Ringloc®+ Hip System]
| 00887868342165 | PT-116066 |
| 00887868342158 | PT-116064 |
| 00887868342141 | PT-116062 |
| 00887868342134 | PT-116060 |
| 00887868342127 | PT-116058 |
| 00887868342110 | PT-116056 |
| 00887868342103 | PT-116054 |
| 00887868342097 | PT-116052 |
| 00887868342080 | PT-116050 |
| 00887868342073 | PT-116048 |
| 00887868342066 | PT-116046 |
| 00887868342059 | PT-116044 |
| 00887868342042 | PT-116042 |
| 00887868342035 | PT-106080 |
| 00887868342028 | PT-106078 |
| 00887868342011 | PT-106076 |
| 00887868342004 | PT-106074 |
| 00887868341991 | PT-106072 |
| 00887868341984 | PT-106070 |
| 00887868341977 | PT-106068 |
| 00887868341960 | PT-106066 |
| 00887868341953 | PT-106064 |
| 00887868341946 | PT-106062 |
| 00887868341939 | PT-106060 |
| 00887868341922 | PT-106058 |
| 00887868341915 | PT-106056 |
| 00887868341908 | PT-106054 |
| 00887868341892 | PT-106052 |
| 00887868341885 | PT-106050 |
| 00887868341878 | PT-106048 |
| 00887868341861 | PT-106046 |
| 00887868341854 | PT-106044 |
| 00887868341847 | PT-104072 |
| 00887868341830 | PT-104066 |
| 00887868341823 | PT-104064 |
| 00887868341816 | PT-104062 |
| 00887868341809 | PT-104060 |
| 00887868341793 | PT-104058 |
| 00887868341786 | PT-104056 |
| 00887868341779 | PT-104054 |
| 00887868341762 | PT-104052 |
| 00887868341755 | PT-104050 |
| 00887868341748 | PT-104048 |
Trademark Results [Regenerex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REGENEREX 78753529 3331701 Live/Registered |
Biomet Manufacturing, LLC 2005-11-14 |
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