ROEKO Double adapter

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: ROEKO Double adapter FDA UDI
Generic Name: Dental suction system cannula, reusable FDA UDI
Model / Reference: 463000 FDA UDI

Identifiers

Catalog Number: 463000 FDA UDI
Primary DI / UDI-DI: E1654630000 FDA UDI
FDA Product Code: JOL FDA UDI
GMDN Term: Dental suction system cannula, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 6.5 Millimeter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI

Category: Dental suction system cannula, reusable

ROEKO Double adapter by Coltène/Whaledent AG — 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: Coltène/Whaledent AG

Sources (1)

FDA UDI f9993203-5a6c-4b9a-874f-6ecb08d5e209 35 fields · synced May 30, 2026