Skip to content

Integral Drainage Set 910412

by Integra Neurosciences Implant (France)

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780034193 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2907-2016 FDA Class II initiated 23 Aug 2016

    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Integral Drainage Set
Generic Name
Ventricular cerebrospinal fluid drainage catheterization kit
Model / Ref / Catalog
910412
Primary DI / UDI-DI
10381780034193
510(k) Number
FDA Product Code
JXG
GMDN Term
Ventricular cerebrospinal fluid drainage catheterization kit
Device Class
Class II
Regulation Number
882.5550
GUDID distribution status
Not in Commercial Distribution

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No