| Primary Device ID | 00081317027133 |
| NIH Device Record Key | d322a9db-8242-4c64-a5f0-cb5d2b1f6dab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENTOR MemoryGel Breast Implant |
| Version Model Number | SHPB685 |
| Catalog Number | SHPB-685 |
| 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 | true |
| 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 | |
| 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 | 00081317027133 [Primary] |
| FTR | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-23 |
| Device Publish Date | 2022-02-15 |
| 00081317025375 | Smooth High Profile Xtra 790cc |
| 00081317025368 | Smooth High Profile Xtra 755cc |
| 00081317025351 | Smooth High Profile Xtra 700cc |
| 00081317025344 | Smooth High Profile Xtra 650cc |
| 00081317025337 | Smooth High Profile Xtra 595cc |
| 00081317025320 | Smooth High Profile Xtra 560cc |
| 00081317025313 | Smooth High Profile Xtra 535cc |
| 00081317025306 | Smooth High Profile Xtra 490cc |
| 00081317025290 | Smooth High Profile Xtra 465cc |
| 00081317025283 | Smooth High Profile Xtra 450cc |
| 00081317025276 | Smooth High Profile Xtra 415cc |
| 00081317025269 | Smooth High Profile Xtra 380cc |
| 00081317025252 | Smooth High Profile Xtra 355cc |
| 00081317025245 | Smooth High Profile Xtra 335cc |
| 00081317025238 | Smooth High Profile Xtra 285cc |
| 00081317025221 | Smooth High Profile Xtra 260cc |
| 00081317025214 | Smooth High Profile Xtra 235cc |
| 00081317025207 | Smooth High Profile Xtra 200cc |
| 00081317025191 | Smooth High Profile Xtra 180cc |
| 00081317025184 | Smooth High Profile Xtra 150cc |
| 00081317025177 | Smooth Moderate Plus Profile Xtra 755cc |
| 00081317025160 | Smooth Moderate Plus Profile Xtra 685cc |
| 00081317025153 | Smooth Moderate Plus Profile Xtra 645cc |
| 00081317025146 | Smooth Moderate Plus Profile Xtra 630cc |
| 00081317025139 | Smooth Moderate Plus Profile Xtra 605cc |
| 00081317025122 | Smooth Moderate Plus Profile Xtra 560cc |
| 00081317025115 | Smooth Moderate Plus Profile Xtra 545cc |
| 00081317025108 | Smooth Moderate Plus Profile Xtra 525cc |
| 00081317025092 | Smooth Moderate Plus Profile Xtra 490cc |
| 00081317025085 | Smooth Moderate Plus Profile Xtra 465cc |
| 00081317025078 | Smooth Moderate Plus Profile Xtra 440cc |
| 00081317025061 | Smooth Moderate Plus Profile Xtra 405cc |
| 00081317025054 | Smooth Moderate Plus Profile Xtra 370cc |
| 00081317025047 | Smooth Moderate Plus Profile Xtra 350cc |
| 00081317025030 | Smooth Moderate Plus Profile Xtra 325cc |
| 00081317025023 | Smooth Moderate Plus Profile Xtra 295cc |
| 00081317025016 | Smooth Moderate Plus Profile Xtra 270cc |
| 00081317025009 | Smooth Moderate Plus Profile Xtra 240cc |
| 00081317024996 | Smooth Moderate Plus Profile Xtra 215cc |
| 00081317024989 | Smooth Moderate Plus Profile Xtra 190cc |
| 00081317024972 | Smooth Moderate Plus Profile Xtra 160cc |
| 00081317024965 | Smooth Moderate Plus Profile Xtra 130cc |
| 00081317024958 | Smooth Moderate Plus Profile Xtra 115cc |
| 00081317007210 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 700cc |
| 00081317007203 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 650cc |
| 00081317007197 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 590cc |
| 00081317007180 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 535cc |
| 00081317007173 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 480cc |
| 00081317007166 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 455cc |
| 00081317007159 | SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 430cc |