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PolypVac® 4.0mm Microdebrider

by Laurimed, LLC

PolypVac® 4.0mm Microdebrider (FG-000017) is a Class II device made by Laurimed, LLC, listed in FDA GUDID since 10 Oct 2016 (UDI-DI 00862519000328), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862519000328 UDI-DI Date10 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
PolypVac®
Generic name
ENT shaver system handpiece
Model / Ref / Catalog
4.0mm Microdebrider, FG-000017
Primary DI / UDI-DI
00862519000328
FDA product code
ERL
GMDN term
ENT shaver system handpiece
Device class
Class II
Regulation number
874.4250
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece).

Other devices from Laurimed, LLC

See all devices from Laurimed, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)