Sapphire II Pro

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Sapphire II Pro FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Balloon Dilatation Catheter FDA UDI
Model / Reference: 220-103-5UU FDA UDI
Description: Balloon Dilatation Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 06934955942167 FDA UDI
FDA Product Code: LOX FDA UDI
LIT FDA UDI
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
870.1250 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: Length — 10 Millimeter FDA UDI
Outer Diameter — 2.0 Millimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

Sapphire II Pro 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 bad8ed2b-ce21-4329-9f4c-1d1e6378dbf0 35 fields · synced Jun 1, 2026