Ebony HP PTA OTW 0.035" Catheter

FDA UDI

Class II (US FDA UDI)

by Natec Medical Ltd

Identity

Trade Name: Ebony HP PTA OTW 0.035" Catheter FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Ebony HP PTA OTW 0.035" Catheter, 3.00 X 100 MM /Shaft Length 75 CM FDA UDI
Model / Reference: PH073_00-100S FDA UDI
Description: Ebony HP PTA OTW 0.035" Catheter, 3.00 X 100 MM /Shaft Length 75 CM FDA UDI

Identifiers

Primary DI / UDI-DI: 06091403542604 FDA UDI
FDA Product Code: LIT FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 3.00 Millimeter FDA UDI
Balloon Length — 100 Millimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

Ebony HP PTA OTW 0.035" Catheter by Natec Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
Advocate™ — Merit Medical Systems, Inc. · Class II
Senri — KANEKA Corporation · Class IIa
Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · 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: Natec Medical Ltd

Sources (1)

FDA UDI 403f172e-09e6-4c7f-adbf-df51cdb62fec 36 fields · synced May 30, 2026