Skip to content

NA EZ Glide Manipulator

by C R I

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852073002715 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Uterine manipulator, single-use
Model / Ref / Catalog
EZ Glide Manipulator, TMI1171
Primary DI / UDI-DI
00852073002715
510(k) Number
FDA Product Code
LKF
GMDN Term
Uterine manipulator, single-use
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5 Millimeter
Length — 37 Centimeter

Related devices

Category: Uterine manipulator, single-use

Cleared under the same submission (K974357)

Other devices from C R I

See all devices from C R I →

Properties

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

Other properties (9)

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