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Surgical Direct SD48-1716

by Surgical Direct, Inc.

Surgical Direct SD48-1716 is a peritoneal catheter stylet (FDA Class I; FDA product code GEN, Forceps, General & Plastic Surgery) made by Surgical Direct, Inc., listed in FDA GUDID since 10 Apr 2023 (UDI-DI B382SD4817160), 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 NumberB382SD4817160 UDI-DI Date10 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  • Withdrawn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
Peritoneal catheter stylet
Model / Ref / Catalog
SD48-1716
Primary DI / UDI-DI
B382SD4817160
FDA product code
GEN
GMDN term
Peritoneal catheter stylet
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
Other properties (13, all answered No)