MozecTM Rx PTCA Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by Meril Life Sciences Private Limited

Identity

Trade Name: MozecTM Rx PTCA Balloon Dilatation Catheter FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: MozecTM Rx PTCA Balloon Dilatation Catheter, 2.75 mm x 30 mm, Rapid Exchange FDA UDI
Model / Reference: MOZ27530 FDA UDI
Description: MozecTM Rx PTCA Balloon Dilatation Catheter, 2.75 mm x 30 mm, Rapid Exchange FDA UDI

Identifiers

Catalog Number: MOZ27530 FDA UDI
Primary DI / UDI-DI: 18904224907833 FDA UDI
FDA Product Code: LOX FDA UDI
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.75 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Coronary angioplasty balloon catheter, basic

MozecTM Rx PTCA Balloon Dilatation Catheter by Meril Life Sciences Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Meril Life Sciences Private Limited

Sources (1)

FDA UDI 270f999e-2629-472d-88c6-d6cb77d4742c 37 fields · synced Jun 8, 2026