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NA Semiflex 0.125 cm³ ion chamber

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 NumberEPTWTN310100 UDI-DI Date27 Apr 2017ListedStatusListed 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  • Withdrawn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

Generic Name
Ionization chamber radiation measuring probe
Model / Ref / Catalog
Semiflex 0.125 cm³ ion chamber, TN31010
Primary DI / UDI-DI
EPTWTN310100
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

Related devices

Category: Ionization chamber radiation measuring probe

Cleared under the same submission (K972212)

Show all (12)

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Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Expiration Date: No