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Surgistar 2420

by Surgistar Inc.

Surgistar 2420 is a keratome blade (FDA Class I; FDA product code GDX, Scalpel, One-Piece) made by Surgistar Inc., listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00878799005311), 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 Number00878799005311 UDI-DI Date8 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Surgistar
Generic name
Keratome blade, single-use
Model / reference
2420
Primary DI / UDI-DI
00878799005311
FDA product code
GDX
GMDN term
Keratome blade, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GDX (Scalpel, One-Piece).

Other devices from Surgistar Inc.

  • Surgistar 8191

    Class I
  • Surgistar 8119

    Class I
  • Surgistar 196469

    Class I
  • Surgistar 8120

    Class I

See all devices from Surgistar Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)