Sapphire NC Plus

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Sapphire NC Plus FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter FDA UDI
Model / Reference: 250-083-2U FDA UDI
Description: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 06934955934612 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

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.0 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI

Category: Coronary angioplasty balloon catheter, basic

Sapphire NC Plus by OrbusNeich Medical (ShenZhen) Co., Ltd. — 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: OrbusNeich Medical (ShenZhen) Co., Ltd.

Sources (1)

FDA UDI 895eb731-0271-401e-b50b-15f5dfdecc17 36 fields · synced May 31, 2026