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Malibu 91-6116

by SeaSpine Orthopedics Corporation

Malibu 91-6116 is a Class I device made by SeaSpine Orthopedics Corporation, listed in FDA GUDID since 2 May 2016 (UDI-DI 10889981082307), 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 Number10889981082307 UDI-DI Date2 May 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  • Withdrawn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
Malibu
Generic name
ENT probe, reusable
Model / Ref / Catalog
91-6116
Primary DI / UDI-DI
10889981082307
FDA product code
HXB
GMDN term
ENT probe, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: ENT probe, reusable

Similar devices in this category

Other devices filed under ENT probe, reusable.

Other devices from SeaSpine Orthopedics Corporation

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)