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Edwards Reusable Rail

FDA UDI

Class I (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
Edwards Reusable Rail FDA UDI
Generic Name
Cardiac implantation catheter holder, reusable FDA UDI
Device Name
Edwards Reusable Rail FDA UDI
Model / Reference
10000RL FDA UDI
Description
Edwards Reusable Rail FDA UDI

Identifiers

Catalog Number
10000RL FDA UDI
Primary DI / UDI-DI
00690103219500 FDA UDI
FDA Product Code
QWA FDA UDI
GMDN Term
Cardiac implantation catheter holder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3955 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cardiac implantation catheter holder, reusable

Edwards Reusable Rail by Edwards Lifesciences LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac implantation catheter 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 7d36b694-6d9a-4a82-a2ca-162094acbc55 36 fields · synced Jun 8, 2026