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Resectr Resection Device 5FR (1.65 mm) M0065907051

by Axora Medical, 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 Number00850083954154 UDI-DI Date24 Sep 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  • Withdrawn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
Resectr Resection Device 5FR (1.65 mm)
Generic Name
Hysteroscopic resection device
Model / Ref / Catalog
M0065907051
Description
(1) Resectr Tissue Resection Device 5FR (1.65 mm) (1) Vacuum Tube Adapter
Primary DI / UDI-DI
00850083954154
FDA Product Code
HIH
GMDN Term
Hysteroscopic resection device
Device Class
Class II
Regulation Number
884.1690
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 5 French
Outer Diameter — 1.65 Millimeter

Other devices from Axora Medical, Inc.

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