| Primary Device ID | 10081317028113 |
| NIH Device Record Key | 86a3d8ff-5d8e-4d8e-8537-0c6836cfd9d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENTOR MemoryGel Xtra Resterilizable Gel Sizer |
| Version Model Number | RSZSMHX580S |
| Catalog Number | RSZ-SMHX-580S |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10081317028113 [Primary] |
| MRD | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
[10081317028113]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-09 |
| Device Publish Date | 2021-02-01 |
| 00081317026556 | High Profile Xtra, For Use With THPX-765 |
| 00081317026549 | High Profile Xtra, For Use With THPX-725 |
| 00081317026532 | High Profile Xtra, For Use With THPX-680 |
| 00081317026525 | High Profile Xtra, For Use With THPX-620 |
| 00081317026518 | High Profile Xtra, For Use With THPX-570 |
| 00081317026501 | High Profile Xtra, For Use With THPX-545 |
| 00081317026495 | High Profile Xtra, For Use With THPX-515 |
| 00081317026488 | High Profile Xtra, For Use With THPX-470 |
| 00081317026471 | High Profile Xtra, For Use With THPX-455 |
| 00081317026464 | High Profile Xtra, For Use With THPX-425 |
| 00081317026457 | High Profile Xtra, For Use With THPX-405 |
| 00081317026440 | High Profile Xtra, For Use With THPX-365 |
| 00081317026433 | High Profile Xtra, For Use With THPX-340 |
| 00081317026426 | High Profile Xtra, For Use With THPX-325 |
| 00081317026419 | High Profile Xtra, For Use With THPX-285 |
| 00081317026402 | High Profile Xtra, For Use With THPX-255 |
| 00081317026396 | High Profile Xtra, For Use With THPX-230 |
| 00081317026389 | High Profile Xtra, For Use With THPX-200 |
| 00081317026372 | High Profile Xtra, For Use With THPX-175 |
| 00081317026365 | High Profile Xtra, For Use With THPX-150 |
| 00081317026358 | High Profile Xtra, For Use With SHPX-790 |
| 00081317026341 | High Profile Xtra, For Use With SHPX-755 |
| 00081317026334 | High Profile Xtra, For Use With SHPX-700 |
| 00081317026327 | High Profile Xtra, For Use With SHPX-650 |
| 00081317026310 | High Profile Xtra, For Use With SHPX-595 |
| 00081317026303 | High Profile Xtra, For Use With SHPX-560 |
| 00081317026297 | High Profile Xtra, For Use With SHPX-535 |
| 00081317026280 | High Profile Xtra, For Use With SHPX-490 |
| 00081317026273 | High Profile Xtra, For Use With SHPX-465 |
| 00081317026266 | High Profile Xtra, For Use With SHPX-450 |
| 00081317026259 | High Profile Xtra, For Use With SHPX-415 |
| 00081317026242 | High Profile Xtra, For Use With SHPX-380 |
| 00081317026235 | High Profile Xtra, For Use With SHPX-355 |
| 00081317026228 | High Profile Xtra, For Use With SHPX-335 |
| 00081317026211 | High Profile Xtra, For Use With SHPX-285 |
| 00081317026204 | High Profile Xtra, For Use With SHPX-260 |
| 00081317026198 | High Profile Xtra, For Use With SHPX-235 |
| 00081317026181 | High Profile Xtra, For Use With SHPX-200 |
| 00081317026174 | High Profile Xtra, For Use With SHPX-180 |
| 00081317026167 | High Profile Xtra, For Use With SHPX-150 |
| 00081317026150 | Moderate Plus Profile Xtra, 755cc |
| 00081317026143 | Moderate Plus Profile Xtra, 685cc |
| 00081317026136 | Moderate Plus Profile Xtra, 645cc |
| 00081317026129 | Moderate Plus Profile Xtra, 630cc |
| 00081317026112 | Moderate Plus Profile Xtra, 605cc |
| 00081317026105 | Moderate Plus Profile Xtra, 560cc |
| 00081317026099 | Moderate Plus Profile Xtra, 545cc |
| 00081317026082 | Moderate Plus Profile Xtra, 525cc |
| 00081317026075 | Moderate Plus Profile Xtra, 490cc |
| 00081317026068 | Moderate Plus Profile Xtra, 465cc |