Sapphire II PRO Balloon Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Sapphire II PRO Balloon Dilatation Catheter FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter FDA UDI
Model / Reference: 501201012 FDA UDI
Description: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 06934955950070 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: Balloon Diameter — 1.25 Millimeter FDA UDI
Balloon Length — 10 Millimeter FDA UDI

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

Sapphire II PRO Balloon Dilatation Catheter by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary angioplasty balloon catheter, basic.

REBEL™ — Boston Scientific · Class III
SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
NC STORMER® OTW — MEDTRONIC, INC. · Class II
Pantera Pro — Biotronik, Inc. · Class II
SPRINTER LEGEND — MEDTRONIC, INC. · Class II
SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
SPRINTER LEGEND — MEDTRONIC, INC. · Class II
Emerge™ — Boston Scientific · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OrbusNeich Medical (ShenZhen) Co., Ltd.

Sources (1)

FDA UDI 54ad91ab-9a33-4f48-b4bc-cbcc58c26f4a 36 fields · synced May 30, 2026