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Carter-Thomason II Port Closure System CTI-1015P

by CooperSurgical, Inc.

Ref CTI-1015PModel CTI-1012P

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888937TD060ZM Basic UDI-DI 60888937002920UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number60888937002920 UDI-DI Date18 Aug 2016ListedStatusListed 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.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0985-2024 FDA Class II initiated 29 Aug 2023

    Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

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  • Withdrawn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
Carter-Thomason® II Port Closure System EUDAMED
Carter-Thomason II Port Closure System GUDID
Generic Name
Laparoscopic wound closure thread
Device Name
Carter-Thomason II Port Closure System™
Model / Reference
CTI-1015P, CTI-1012P
Primary DI / UDI-DI
60888937002920
Basic UDI-DI
0888937TD060ZM
510(k) Number
FDA Product Code
GCJ
EMDN Code
H900899 Single-use instruments for sutures - other
GMDN Term
Laparoscopic wound closure thread
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Cleared under the same submission (K980123)

Show all (12)

Other devices from CooperSurgical, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No