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PERLA TL Cortical NAV-Instruments NAV-IN 34 45-N

by Spineart

Ref NAV-IN 34 45-N

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 Number1764045086NAVMETAPINSTRUC Basic UDI-DI 07640450868626UDI-DIDate28 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640450868626 UDI-DI Date29 Mar 2021ListedStatusListed 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  • Withdrawn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
Perla® Tl Nav Perla Tl Nav. Cortical Tap Ø4.5 (Ø4.5 Screw) EUDAMED
PERLA TL Cortical NAV-Instruments GUDID
Generic Name
Bone tap, reusable
Device Name
NAVIGATION REUSABLE INSTRUMENTS IIa TAP
Model / Ref / Catalog
NAV-IN 34 45-N
Primary DI / UDI-DI
07640450868626
Basic UDI-DI
1764045086NAVMETAPINSTRUC
Direct Marketing DI
07640450868626
FDA Product Code
OLO
EMDN Code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN Term
Bone tap, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Bone tap, reusable

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Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No