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Fogarty Softjaw

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
FOGARTY SOFTJAW FDA UDI
Generic Name
Vascular clamp, single-use FDA UDI
Device Name
FOGARTY SPRING CLIPS 12MM FDA UDI
Model / Reference
CSOFT12 FDA UDI
Description
FOGARTY SPRING CLIPS 12MM FDA UDI

Identifiers

Catalog Number
CSOFT12 FDA UDI
Primary DI / UDI-DI
00690103044188 FDA UDI
510(k) Number
K832554 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Vascular clamp, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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

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

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: Vascular clamp, single-use

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

Similar devices

Also classified as Vascular clamp, single-use.

Cleared under the same submission

K832554 also covers:

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 0cec757f-12f6-4630-9d60-8b1cbf531e0f 38 fields · synced Jun 8, 2026