Primary Device ID | 10081317031090 |
NIH Device Record Key | 6686ab2e-e433-426e-ac15-73e94a8c526b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MENTOR MemoryGel Enhance Breast Implant |
Version Model Number | SUHE1445 |
Catalog Number | SUHE-1445 |
Company DUNS | 167450993 |
Company Name | MENTOR TEXAS L.P. |
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 | true |
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)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx | |
Phone | +1(800)235-5731 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10081317031090 [Primary] |
MRD | Mammary sizer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-09 |
Device Publish Date | 2025-04-01 |
10081317031106 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 930cc |
10081317031090 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1445cc |
10081317031083 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1340cc |
10081317031076 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1240cc |
10081317031069 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1135cc |
10081317031052 | Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1030cc |