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Edwards Dilator Kit

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS DILATOR KIT FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
EDWARDS DILATOR KIT FDA UDI
Model / Reference
9100DKSA FDA UDI
Description
EDWARDS DILATOR KIT FDA UDI

Identifiers

Catalog Number
9100DKSA FDA UDI
Primary DI / UDI-DI
00690103192391 FDA UDI
FDA Product Code
DRE FDA UDI
NPT FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1310 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

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular catheter introduction set, nonimplantableAortic transcatheter heart valve bioprosthesis, stent-like framework

Edwards Dilator Kit by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic transcatheter heart valve bioprosthesis, stent-like framework.

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 eae3668e-b0c5-42f1-98e3-43b5bb1c3a8d 37 fields · synced Jun 8, 2026