| Primary Device ID | 00690103185812 |
| NIH Device Record Key | df12944f-a56a-464b-837e-9c86b16e87de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERIMOUNT MAGNA EASE AORTIC SIZER 27MM |
| Version Model Number | 1133 |
| Catalog Number | 113327MM |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103185812 [Primary] |
| DTI | Sizer, Heart-Valve, Prosthesis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
[00690103185812]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-19 |
| Device Publish Date | 2026-02-11 |
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| 00690103221329 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 2026-02-25 Pulmonic Delivery System - 23 mm (Gen 2) (US) |
| 00690103221336 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 2026-02-25 Pulmonic Delivery System - 26 mm (Gen 2) (US) |
| 00690103221343 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 2026-02-25 Pulmonic Delivery System - 29 mm (Gen 2) (US) |
| 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM | 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE |
| 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM | 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE |
| 00690103019377 - AORTIC TRUE-SIZE OBTURATOR 23MM | 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE |
| 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM | 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE |