Skip to content

EIT PLIF Instrument Tray PEC00101

by EIT Emerging Implant Technologies GmbH EUDAMEDGUDID

Active European Union Open recall (shared submission)

Ref PEC00101Model EIT Instrument Sterilization Trays

Regulatory status

as of 29 Oct 2026

Recall ongoing. 2 ongoing FDA recalls on shared 510(k) K170503: the recalled product is another device cleared under the same submission. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4260397a00001D4 Basic UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260397088227 UDI-DIDate5 Jan 2018ListedStatusListed 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  • Withdrawn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

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.

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1323-2022 FDA Class II initiated 20 May 2022 on shared 510(k) K170503
    • Ongoing Z-1324-2022 FDA Class II initiated 20 May 2022 on shared 510(k) K170503

    Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Trade Name
EIT PLIF Instrument Tray
Generic Name
Device sterilization/disinfection container, reusable
Device Name
EIT Cervical Instruments Trays EIT ALIF Instrument Trays EIT LLIF Instrument Trays EIT PLIF Instrument Trays EIT TLIF instrument Trays
Model / Reference
PEC00101, EIT Instrument Sterilization Trays
Primary DI / UDI-DI
04260397088227
Basic UDI-DI
4260397a00001D4
510(k) Number
FDA Product Code
FSM
EMDN Code
V0499 Clinical use containers (non-IVD) - other
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Device sterilization/disinfection container, reusable

Cleared under the same submission (K170503)

Show all (12)

Other devices from EIT Emerging Implant Technologies GmbH

See all devices from EIT Emerging Implant Technologies GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

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