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Surgical Direct SD826-08

by Surgical Direct, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB382SD826080 UDI-DI Date6 Apr 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  • Withdrawn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
Endoscope sheath, reusable
Model / Ref / Catalog
SD826-08
Primary DI / UDI-DI
B382SD826080
FDA product code
NBH
GMDN term
Endoscope sheath, reusable
Device class
Class I
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Other devices from Surgical Direct, Inc.

See all devices from Surgical Direct, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No