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Surgical Direct SD200-035

by Surgical Direct, Inc.

Surgical Direct SD200-035 is a Class I device made by Surgical Direct, Inc., listed in FDA GUDID since 18 May 2023 (UDI-DI B382SD2000350), 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 NumberB382SD2000350 UDI-DI Date18 May 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  • Withdrawn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
Sterilization container mat
Model / Ref / Catalog
SD200-035
Description
Sterilization Case With Silicone Mat, 11''L x 7''W x 1 1/2''H
Primary DI / UDI-DI
B382SD2000350
FDA product code
GEN
GMDN term
Sterilization container mat
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Sterilization container mat

Similar devices

Other devices filed under FDA product code GEN (Forceps, General & Plastic Surgery).

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)