Skip to content

Surgical Direct SDI06004

by Surgical Direct, Inc.

Surgical Direct SDI06004 is a Class I device made by Surgical Direct, Inc., listed in FDA GUDID since 3 Dec 2022 (UDI-DI B382SDI060040), 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 NumberB382SDI060040 UDI-DI Date3 Dec 2022ListedStatusListed 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  • Withdrawn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
Orthopaedic joint/limb rongeur
Model / Ref / Catalog
SDI06004
Primary DI / UDI-DI
B382SDI060040
FDA product code
HTX
GMDN term
Orthopaedic joint/limb rongeur
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic joint/limb rongeur

Similar devices in this category

Other devices filed under Orthopaedic joint/limb rongeur.

Other devices from Surgical Direct, Inc.

See all devices from Surgical Direct, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)