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iCast Covered Stent System, 8mmX38mmX80cm

FDA UDI

Class III (US FDA UDI)

by Atrium Medical Corp.

Identity

Trade Name
iCast Covered Stent System, 8mmX38mmX80cm FDA UDI
Generic Name
Peripheral artery endovascular stent-graft, non-medicated FDA UDI
Device Name
iCast Covered Stent System, 8mmX38mmX80cm FDA UDI
Model / Reference
48838 FDA UDI
Description
iCast Covered Stent System, 8mmX38mmX80cm FDA UDI

Identifiers

Catalog Number
48838 FDA UDI
Primary DI / UDI-DI
00650862488388 FDA UDI
PMA Number
P120003 FDA UDI
FDA Product Code
PRL FDA UDI
GMDN Term
Peripheral artery endovascular stent-graft, non-medicated 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Stent Diameter — 8 Millimeter FDA UDI
Shaft Length — 38 Millimeter FDA UDI
Catheter Length — 80 Centimeter FDA UDI

Category: Peripheral artery endovascular stent-graft, non-medicated

iCast Covered Stent System, 8mmX38mmX80cm by Atrium Medical Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery endovascular stent-graft, non-medicated.

Cleared under the same submission

P120003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atrium Medical Corp.

Sources (1)

  • FDA UDI 0130d8cf-def1-400d-8790-b63edcb17fa0 38 fields · synced May 30, 2026