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Vent. Tube Diabolo Type Gold Platinum

FDA UDI

Class II (US FDA UDI)

by Heinz Kurz

Identity

Trade Name
Vent. Tube Diabolo Type Gold Platinum FDA UDI
Generic Name
Middle ear moulding FDA UDI
Device Name
Middle ear implantable mould FDA UDI
Model / Reference
1015053 FDA UDI
Description
Middle ear implantable mould FDA UDI

Identifiers

Catalog Number
1015053 FDA UDI
Primary DI / UDI-DI
EHKM10150531 FDA UDI
510(k) Number
K973226 FDA UDI
FDA Product Code
ETD FDA UDI
GMDN Term
Middle ear moulding FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Middle ear moulding

Vent. Tube Diabolo Type Gold Platinum by Heinz Kurz — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear moulding.

Cleared under the same submission

K973226 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heinz Kurz

Sources (1)

  • FDA UDI edd5716e-e351-4a8d-b67d-504906fcb46c 36 fields · synced May 30, 2026