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LiNA OperaScope™ Tubing & Drape kit OP-TDK-6

by LiNA Medical AG

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05708265018024 UDI-DI Date3 Apr 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  • Withdrawn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
LiNA OperaScope™ Tubing & Drape kit
Generic Name
Hysteroscopic/cystoscopic distention tubing set
Model / Reference
OP-TDK-6
Primary DI / UDI-DI
05708265018024
FDA Product Code
PXU
GMDN Term
Hysteroscopic/cystoscopic distention tubing set
Device Class
Class I
Regulation Number
878.4200
GUDID distribution status
In Commercial Distribution

Other devices from LiNA Medical AG

See all devices from LiNA Medical AG →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch 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
  • Serial Number: No