FDA.reportPublic FDA data

DISPOSABLE HANDLE FOR VALVES/SIZERS

Primary DI
50690103019242
Brand
DISPOSABLE HANDLE FOR VALVES/SIZERS
Company
Edwards Lifesciences LLC
Model
1126
Catalog number
1126
Device description
DISPOSABLE HANDLE FOR VALVES/SIZERS
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTISizer, Heart-Valve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103019242PackageGS110In Commercial Distribution
00690103019247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010301924250690103019242
00690103019247006901030192476901030192470690103019247

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis holder, single-useA hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067052964Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067052971Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067052988Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054197NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054203NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054210NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054227NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054234NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054241NAST. JUDE MEDICAL, INC.DTI2026-07-08
00763000990657Mosaic Neo™ S310MNHMEDTRONIC, INC.DTI2026-04-13
00763000990664Mosaic Neo™ S310MNSMEDTRONIC, INC.DTI2026-04-13
00690103019643HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019650HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019674HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019698HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019704HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019711HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019742HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019759HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019780HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06