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microDiamond

FDA UDI

Class II (US FDA UDI)

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Identity

Trade Name
microDiamond FDA UDI
Generic Name
Ionization chamber radiation measuring probe FDA UDI
Model / Reference
microDiamond FDA UDI

Identifiers

Catalog Number
TM60019 FDA UDI
Primary DI / UDI-DI
EPTWTM600190 FDA UDI
510(k) Number
K010916 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Ionization chamber radiation measuring probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ionization chamber radiation measuring probe

microDiamond by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ionization chamber radiation measuring probe.

Cleared under the same submission

K010916 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Sources (1)

  • FDA UDI 46eecd00-14cf-42d9-80bd-1378326b1db6 34 fields · synced Jun 9, 2026