Primary Device ID | 00690103210132 |
NIH Device Record Key | 36ae6492-4b77-4b41-9713-cdaf1790434a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MITRIS Handle 1140M |
Version Model Number | 1140M |
Catalog Number | 1140M |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00690103210132 [Primary] |
DTJ | Holder, Heart-Valve, Prosthesis |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-28 |
Device Publish Date | 2024-10-18 |
00690103019063 - HEART VALVE HANDLE ACCESSORY | 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV |
50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS | 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS |
00690103019339 - HEART VALVE ACCESSOR | 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S |
00690103166989 - HEART VALVE ACCESSOR | 2024-10-28 MITRAL SIZER HANDLE |
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 | 2024-10-28 RING HANDLE - EXTENDED 4" |
00690103186437 - FLEXIBLE HANDLE | 2024-10-28 FLEXIBLE HANDLE |
00690103210132 - MITRIS Handle 1140M | 2024-10-2811400M valve handle |
00690103210132 - MITRIS Handle 1140M | 2024-10-28 11400M valve handle |
00690103217773 - Edwards EVOQUE Loading System | 2024-10-11 Edwards EVOQUE Loading System |