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My3D® Personalized Pelvic Reconstruction PV-50TRY-04T

by Onkos Surgical, Inc.

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 NumberB278PV50TRY04T0 UDI-DI Date4 Aug 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  • Withdrawn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
My3D® Personalized Pelvic Reconstruction
Generic Name
Instrument tray, reusable
Model / Ref / Catalog
PV-50TRY-04T
Primary DI / UDI-DI
B278PV50TRY04T0
FDA Product Code
LPH
GMDN Term
Instrument tray, reusable
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Onkos Surgical, Inc.

See all devices from Onkos Surgical, Inc. →

Properties

  • Lot / Batch Number

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No