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Uterine Manipulator/ Injector

by Medgyn Products, Inc. 3 variants

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 NumberM803003276515 UDI-DI Date8 Jun 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  • Withdrawn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
Uterine Manipulator
Generic Name
Uterine injector
Model / Ref / Catalog
Uterine Manipulator/ Injector, TMI1151
Primary DI / UDI-DI
M803003276515
FDA Product Code
LKF
GMDN Term
Uterine injector
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Medgyn Products, Inc.

See all devices from Medgyn Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No