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A Handle Compatible With Ring Holders (5100 +5 more)

FDA UDI

Class I (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 FDA UDI
Generic Name
Heart valve prosthesis holder, reusable FDA UDI
Device Name
RING HANDLE - EXTENDED 4" FDA UDI
Model / Reference
1151 FDA UDI
Description
RING HANDLE - EXTENDED 4" FDA UDI

Identifiers

Catalog Number
1151 FDA UDI
Primary DI / UDI-DI
00690103177701 FDA UDI
FDA Product Code
DTJ FDA UDI
GMDN Term
Heart valve prosthesis holder, reusable FDA UDI
Models / Variants
5100 FDA UDI
4900 FDA UDI
4100 FDA UDI
4200 FDA UDI
4450 FDA UDI
46 FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3935 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve prosthesis holder, reusable

A Handle Compatible With Ring Holders (5100 +5 more) by Edwards Lifesciences LLC — Class I — FDA UDI — listed in FDA GUDID — 6 models

Similar devices

Also classified as Heart valve prosthesis holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI eff17967-9916-42e3-9c63-31245944540c 36 fields · synced Jun 8, 2026