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IMPEDE-FX Embolization Plug

FDA UDI

Class II (US FDA UDI)

by Shape Memory Medical Inc

Identity

Trade Name
IMPEDE-FX Embolization Plug FDA UDI
Generic Name
Extraluminal vascular occluder, single-use FDA UDI
Device Name
IMPEDE-FX Embolization Plug, 12mm FDA UDI
Model / Reference
IMP-FX-12 FDA UDI
Description
IMPEDE-FX Embolization Plug, 12mm FDA UDI

Identifiers

Catalog Number
IMP-FX-12 FDA UDI
Primary DI / UDI-DI
00810041650054 FDA UDI
510(k) Number
K182390 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Extraluminal vascular occluder, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Extraluminal vascular occluder, single-use

IMPEDE-FX Embolization Plug by Shape Memory Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extraluminal vascular occluder, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shape Memory Medical Inc

Sources (1)

  • FDA UDI 97c52a32-5570-40bb-894f-211740b8a16d 35 fields · synced Jun 9, 2026