InterV-Curve Plus

FDA UDI

Class II (US FDA UDI)

by Pan Medical Us Corporation

Identity

Trade Name: InterV-Curve Plus FDA UDI
Generic Name: Kyphoplasty balloon catheter FDA UDI
Device Name: 13 Gauge 15mm Balloon Kyphoplasty Long Catheter (Micro) FDA UDI
Model / Reference: INTVMC-15-L FDA UDI
Description: 13 Gauge 15mm Balloon Kyphoplasty Long Catheter (Micro) FDA UDI

Identifiers

Catalog Number: INTVMC-15-L FDA UDI
Primary DI / UDI-DI: 15060270907937 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Kyphoplasty balloon catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Kyphoplasty balloon catheter

InterV-Curve Plus by Pan Medical Us Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kyphoplasty balloon catheter.

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BALEX Bone Expander System — Taeyeon Medical Co., Ltd. · Class I
BIOPSYBELL — BIOPSYBELL SRL · Class II
Kypho Balloon Catheter 22/16 — Joline GmbH & Co. KG · Class II
BALEX Bone Expander System — Taeyeon Medical Co., Ltd. · Class I
Kypho Balloon Catheter 16/16 — Joline GmbH & Co. KG · Class II
BIOPSYBELL — BIOPSYBELL SRL · Class II
BIOPSYBELL — BIOPSYBELL SRL · Class II

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: Pan Medical Us Corporation

Sources (1)

FDA UDI 8aee7116-00ea-4cfc-9a23-368cc24194ff 35 fields · synced May 30, 2026