Surgical Direct SD91509590

by Surgical Direct, Inc.

Surgical Direct SD91509590 is a Class I device made by Surgical Direct, Inc., listed in FDA GUDID since 22 Mar 2024 (UDI-DI B382SD915095900), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB382SD915095900 UDI-DI	Date22 Mar 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Surgical Direct
Generic name: Vaginal speculum, reusable
Model / Ref / Catalog: SD91509590

Primary DI / UDI-DI: B382SD915095900
FDA product code: GAF
GMDN term: Vaginal speculum, reusable

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Premarket exempt
Lot / batch number

Other properties (12, all answered No)