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Tornier Long Humeral Nail DHN5800

by Tornier, Inc.

Ref DHN5800Model 08858251006889UY

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006889UY Basic UDI-DI 00846832091034UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832091034 UDI-DI Date22 Mar 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tornier Long Humeral Nail
Generic Name
Arthrodesis intramedullary nail, non-distracting
Device Name
TORNIER HUMERAL NAIL - LONG NAIL - Ti6Al4V - UHMWPE - CLASS IIB - STERILE
Model / Ref / Catalog
DHN5800, 08858251006889UY
Primary DI / UDI-DI
00846832091034
Basic UDI-DI
08858251006889UY
FDA Product Code
HSB
EMDN Code
P09120604 Osteosynthesis nail-screw systems
GMDN Term
Arthrodesis intramedullary nail, non-distracting
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 230 Millimeter
Outer Diameter — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No