Profemur PGHCCLE8
GUDID M684PGHCCLE81
PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 EXT
Microport Orthopedics Inc.
Revision coated hip femur prosthesis| Primary Device ID | M684PGHCCLE81 |
| NIH Device Record Key | 3a3ec5de-2291-47af-8c1c-0f8dd1f85791 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Profemur |
| Version Model Number | PGHCCLE8 |
| Catalog Number | PGHCCLE8 |
| Company DUNS | 079118736 |
| Company Name | Microport Orthopedics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192629250376 [Primary] |
| HIBCC | M684PGHCCLE81 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200007
FDA Product Code
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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 | 2020-11-09 |
| Device Publish Date | 2020-10-30 |
On-Brand Devices [Profemur]
| M684PGHCCS101 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 STD |
| M684PGHCCLE71 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 EXT |
| M684PGHCCE101 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 EXT |
| M684PGHCCLE91 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 EXT |
| M684PGHCCLE81 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 EXT |
| M684PGHCCLE61 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT |
| M684PGHCCLE51 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 EXT |
| M684PGHCCLE41 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 EXT |
| M684PGHCCLE31 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 EXT |
| M684PGHCCLE21 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 EXT |
| M684PGHCCLE11 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 EXT |
| M684PGHCCLS91 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 STD |
| M684PGHCCLS81 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 STD |
| M684PGHCCLS71 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 STD |
| M684PGHCCLS61 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 STD |
| M684PGHCCLS51 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 STD |
| M684PGHCCLS41 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 STD |
| M684PGHCCLS31 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 STD |
| M684PGHCCLS21 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 STD |
| M684PGHCCLS11 | PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 STD |
| M684PRGCME121 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 12 EXTENDED |
| M684PRGCME101 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 10 EXTENDED |
| M684PRGCMS121 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 12 STANDARD |
| M684PRGCMS101 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 10 STANDARD |
| M684PRGCCME81 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 8 EXTENDED |
| M684PRGCCME61 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 6 EXTENDED |
| M684PRGCCME41 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 4 EXTENDED |
| M684PRGCCMS81 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 8 STANDARD |
| M684PRGCCMS61 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 6 STANDARD |
| M684PRGCCMS41 | PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 4 STANDARD |
| 00192629063945 | PROFEMUR RENAISSANCE STEM STANDARD SZ 18 |
| M684PLS0S4171 | PROFEMUR RENAISSANCE STEM STANDARD SZ 17 |
| M684PLS0S4161 | PROFEMUR RENAISSANCE STEM STANDARD SZ 16 |
| M684PLS0S4151 | PROFEMUR RENAISSANCE STEM STANDARD SZ 15 |
| 00192629061354 | PROFEMUR RENAISSANCE STEM STANDARD SZ 14 |
| M684PLS0S4131 | PROFEMUR RENAISSANCE STEM STANDARD SZ 13 |
| 00192629061330 | PROFEMUR RENAISSANCE STEM STANDARD SZ 12 |
| M684PLS0S4111 | PROFEMUR RENAISSANCE STEM STANDARD SZ 11 |
| 00192629061316 | PROFEMUR RENAISSANCE STEM STANDARD SZ 10 |
| 00192629061309 | PROFEMUR RENAISSANCE STEM REDUCED SZ 16 |
| M684PLS0R4151 | PROFEMUR RENAISSANCE STEMREDUCED SZ 15 |
| 00192629061286 | PROFEMUR RENAISSANCE STEMREDUCED SZ 14 |
| 00192629061279 | PROFEMUR RENAISSANCE STEM REDUCED SZ 13 |
| 00192629061262 | PROFEMUR RENAISSANCE STEM REDUCED SZ 12 |
| 00192629061255 | PROFEMUR RENAISSANCE STEM REDUCED SZ 11 |
| M684PLS0R4101 | PROFEMUR RENAISSANCE STEM REDUCED SZ 10 |
Trademark Results [Profemur]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFEMUR 76380670 2692765 Live/Registered |
Wright Medical Technology, Inc. 2002-03-11 |
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