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Operace 80078

by Pb Swiss Tools AG

Operace 80078 is a Class I device made by Pb Swiss Tools AG, listed in FDA GUDID since 24 Sep 2024 (UDI-DI 07610733850785), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07610733850785 UDI-DI Date24 Sep 2024ListedStatusListed 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  • Withdrawn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
Operace
Generic name
Surgical screwdriver, single-use
Model / Ref / Catalog
80078
Primary DI / UDI-DI
07610733850785
FDA product code
HXX
GMDN term
Surgical screwdriver, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical screwdriver, single-use

Similar devices in this category

Other devices filed under Surgical screwdriver, single-use.

Other devices from Pb Swiss Tools AG

See all devices from Pb Swiss Tools AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)