BoNee

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: BoNee FDA UDI
Generic Name: General-purpose endoscopic needle, single-use FDA UDI
Model / Reference: NBI070 FDA UDI

Identifiers

Catalog Number: NBI070 FDA UDI
Primary DI / UDI-DI: 03600040326893 FDA UDI
FDA Product Code: FBK FDA UDI
GMDN Term: General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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: Length — 70 Centimeter FDA UDI
Catheter Gauge — 5 French FDA UDI

Category: General-purpose endoscopic needle, single-use

BoNee by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General-purpose endoscopic needle, single-use.

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Injectra, ScleroTip — Medi-Globe Corporation · Class II
Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I
superDimension — Covidien LP · Class I

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: Coloplast A/S

Sources (1)

FDA UDI f81e1122-c767-4edc-90af-0f23e4c5aca6 36 fields · synced May 30, 2026