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PinPoint 3D MR chamber 0.016 cm³

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPTWTM310250 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PinPoint
Generic Name
Ionization chamber radiation measuring probe
Model / Ref / Catalog
PinPoint 3D MR chamber 0.016 cm³, TM31025
Primary DI / UDI-DI
EPTWTM310250
510(k) Number
FDA Product Code
LHN
GMDN Term
Ionization chamber radiation measuring probe
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K972212)

Show all (12)

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Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No