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Surgical Direct SD04088-11005-2

by Surgical Direct, Inc.

Surgical Direct SD04088-11005-2 is a Class II device made by Surgical Direct, Inc., listed in FDA GUDID since 9 Oct 2023 (UDI-DI B382SD040881100520), 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 NumberB382SD040881100520 UDI-DI Date9 Oct 2023ListedStatusListed 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  • Withdrawn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
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Model / Ref / Catalog
SD04088-11005-2
Primary DI / UDI-DI
B382SD040881100520
FDA product code
GEI
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)