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The OZAKI AVPro Sizer Set TC-OZA-USB1XN

by Tokyo Sentan Geka Chiryo Kenkyu Center, K.K.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number04570057303967 UDI-DI Date17 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
The OZAKI AVPro Sizer Set
Generic Name
Heart valve annulus sizer, single-use
Model / Reference
TC-OZA-USB1XN
Primary DI / UDI-DI
04570057303967
FDA Product Code
DTI
GMDN Term
Heart valve annulus sizer, single-use
Device Class
Class I
Regulation Number
870.3945
GUDID distribution status
In Commercial Distribution

Other devices from Tokyo Sentan Geka Chiryo Kenkyu Center, K.K.

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No