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GEN2 G2OB1616

by Surgix Medical LLC

GEN2 G2OB1616 is a Class I device made by Surgix Medical LLC, listed in FDA GUDID since 11 Apr 2024 (UDI-DI 00840343721930), 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 Number00840343721930 UDI-DI Date11 Apr 2024ListedStatusListed 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  • Withdrawn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
GEN2
Generic name
Vaginal dilator
Model / Ref / Catalog
G2OB1616
Primary DI / UDI-DI
00840343721930
FDA product code
HDQ
GMDN term
Vaginal dilator
Device class
Class I
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 5.25 Inch
Catheter Gauge — 32 French

Related devices

Category: Vaginal dilator

Other devices from Surgix Medical LLC

See all devices from Surgix Medical LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)