| Primary Device ID | 10081317031106 |
| NIH Device Record Key | 9fcb2404-1b5f-45ec-803f-085d583002a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENTOR MemoryGel Enhance Breast Implant |
| Version Model Number | SUHE930 |
| Catalog Number | SUHE-930 |
| 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 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
| xx@xx.xx | |
| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| Phone | +1(800)235-5731 |
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| 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 | 10081317031106 [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 |