Skip to content

OsteoCool™ Bone Access Kit OCN005

by Medtronic Sofamor Danek, Inc.

OsteoCool™ Bone Access Kit OCN005 is a Class I device made by Medtronic Sofamor Danek, Inc., listed in FDA GUDID since 11 Nov 2017 (UDI-DI 00643169802957), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169802957 UDI-DI Date11 Nov 2017ListedStatusListed 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  • Withdrawn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
OsteoCool™ Bone Access Kit
Generic name
Bone access channel kit
Model / reference
OCN005
Primary DI / UDI-DI
00643169802957
FDA product code
LXH
GMDN term
Bone access channel kit
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone access channel kit

Similar devices

Other devices filed under FDA product code LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (9, all answered No)