NXT Tissue HeliX Pro

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: NXT Tissue HeliX Pro FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: Intragastric Balloon System FDA UDI
Model / Reference: M00505490 FDA UDI
Description: Intragastric Balloon System FDA UDI

Identifiers

Catalog Number: M00505490 FDA UDI
Primary DI / UDI-DI: 00191506060060 FDA UDI
FDA Product Code: OCW FDA UDI
QTD FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
876.5983 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

Category: Suturing unit, single-use

NXT Tissue HeliX Pro by Boston Scientific — 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: Boston Scientific

Sources (1)

FDA UDI 816e35c4-b0ab-4d1a-a604-261c0b582db3 34 fields · synced Jun 1, 2026