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Pinnacle 1219-36-058

by Depuy Orthopaedics, Inc. EUDAMEDGUDID

Active European Union

Ref 1219-36-058Model PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029
United StatesGUDID listing GUDID Number10603295014478 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776549 Active Supplemented

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    30 Jun 2026
    Expires
    4 Jun 2029
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Pinnacle
Generic Name
Non-constrained polyethylene acetabular liner
Device Name
Acetabular Liners - MARATHON UHMWPE
Model / Ref / Catalog
1219-36-058, PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE, 121936058
Primary DI / UDI-DI
10603295014478
Basic UDI-DI
0603295a002758X
FDA Product Code
LPH
EMDN Code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3358
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No