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Simpulse 0057621

by Davol Inc.

Simpulse 0057621 is a Class II device made by Davol Inc., listed in FDA GUDID since 23 Dec 2015 (UDI-DI 00801741010415), 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 Number00801741010415 UDI-DI Date23 Dec 2015ListedStatusListed 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  • Withdrawn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
Simpulse
Generic name
Surgical mist irrigation tip
Model / Ref / Catalog
0057621
Primary DI / UDI-DI
00801741010415
FDA product code
FQH
GMDN term
Surgical mist irrigation tip
Device class
Class II
Regulation number
880.5475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical mist irrigation tip

Similar devices

Other devices filed under FDA product code FQH (LAVAGE, JET).

Other devices from Davol Inc.

See all devices from Davol Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)