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DUFNER Instrumente GmbH

FDA UDI

Class II (US FDA UDI)

by DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik

Identity

Trade Name
DUFNER Instrumente GmbH FDA UDI
Generic Name
Boiling water sterilizer FDA UDI
Device Name
MICTEC Suction tube with basket, big central opening, 30° curved, Ø 4.5 mm, 300 mm working length Luer lock connector FDA UDI
Model / Reference
20943-14 FDA UDI
Description
MICTEC Suction tube with basket, big central opening, 30° curved, Ø 4.5 mm, 300 mm working length Luer lock connector FDA UDI

Identifiers

Primary DI / UDI-DI
04063763200625 FDA UDI
510(k) Number
K002877 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Boiling water sterilizer 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Boiling water sterilizer

DUFNER Instrumente GmbH by DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K002877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik

Sources (1)

  • FDA UDI 40dd62aa-2998-4566-bd91-c3d87d1ee801 34 fields · synced May 30, 2026