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Surgical Direct SD916721180

by Surgical Direct, Inc.

Surgical Direct SD916721180 is a Class I device made by Surgical Direct, Inc., listed in FDA GUDID since 6 Jan 2025 (UDI-DI B382SD9167211800), 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 NumberB382SD9167211800 UDI-DI Date6 Jan 2025ListedStatusListed 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  • Withdrawn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
Fixed-diameter cervical dilator, reusable
Model / Ref / Catalog
SD916721180
Primary DI / UDI-DI
B382SD9167211800
FDA product code
EIG
GMDN term
Fixed-diameter cervical dilator, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Fixed-diameter cervical dilator, reusable

Similar devices

Other devices filed under FDA product code EIG (RETRACTOR, ALL TYPES).

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)