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Ascendra 3 Introducer Sheath Set

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
ASCENDRA 3 INTRODUCER SHEATH SET FDA UDI
Generic Name
Catheter introducer FDA UDI
Model / Reference
9120ISA FDA UDI

Identifiers

Catalog Number
9120ISA FDA UDI
Primary DI / UDI-DI
00690103191912 FDA UDI
FDA Product Code
NPT FDA UDI
GMDN Term
Catheter introducer FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Catheter introducer

Ascendra 3 Introducer Sheath Set by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter introducer.

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 c2eb279c-a0bd-499a-9f6f-e4b70d484334 29 fields · synced Jun 8, 2026