Disposable Handle For Valves/Sizers

FDA UDI

Class I (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: DISPOSABLE HANDLE FOR VALVES/SIZERS FDA UDI
Generic Name: Heart valve prosthesis holder, single-use FDA UDI
Device Name: DISPOSABLE HANDLE FOR VALVES/SIZERS FDA UDI
Model / Reference: 1126 FDA UDI
Description: DISPOSABLE HANDLE FOR VALVES/SIZERS FDA UDI

Identifiers

Catalog Number: 1126 FDA UDI
Primary DI / UDI-DI: 00690103019247 FDA UDI
FDA Product Code: DTI FDA UDI
GMDN Term: Heart valve prosthesis holder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.3945 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Heart valve prosthesis holder, single-use

Disposable Handle For Valves/Sizers by Edwards Lifesciences LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI 2201995c-df83-4238-9608-71012d2f3695 36 fields · synced Jun 8, 2026