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Surgical Direct SD12379

by Surgical Direct, Inc.

Surgical Direct SD12379 is a Class II device made by Surgical Direct, Inc., listed in FDA GUDID since 26 Apr 2020 (UDI-DI B382SD123790), 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 NumberB382SD123790 UDI-DI Date26 Apr 2020ListedStatusListed 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  • Withdrawn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
Surgical Direct
Generic name
Surgical irrigation/aspiration system
Model / Ref / Catalog
SD12379
Primary DI / UDI-DI
B382SD123790
FDA product code
GCX
GMDN term
Surgical irrigation/aspiration system
Device class
Class II
Regulation number
880.6740
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 33 Centimeter
Outer Diameter — 5 Millimeter

Related devices

Category: Surgical irrigation/aspiration system

Other devices from Surgical Direct, Inc.

See all devices from Surgical Direct, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)