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Carter-Thomason II Port Closure System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CTI-1015PModel CTI-1012P
Identity
- Trade Name
- Carter-Thomason® II Port Closure System EUDAMEDCarter-Thomason II Port Closure System FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- Carter-Thomason II Port Closure System™ EUDAMEDContents: One XL Suture Passer, One 10/12mm XL Suture Guide and One 15mm XL Suture Guide FDA UDIContents: 1 Suture Passer, 1 10/12mm Suture Guide and 1 15mm Suture Guide FDA UDI
- Model / Reference
- CTI-1015P EUDAMEDFDA UDICTI-1012P EUDAMEDCTXL-P FDA UDI
- Description
- Contents: One XL Suture Passer, One 10/12mm XL Suture Guide and One 15mm XL Suture Guide FDA UDIContents: 1 Suture Passer, 1 10/12mm Suture Guide and 1 15mm Suture Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937002920 EUDAMEDFDA UDI60888937002975 FDA UDI
- Basic UDI-DI
- 0888937TD060ZM EUDAMED
- 510(k) Number
- K980123 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- H900899 SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER EUDAMED
- GMDN Term
- Laparoscopic wound closure thread FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic wound closure thread
Carter-Thomason II Port Closure System by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic wound closure thread.
- Monopolar posts long for handles — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Lap-port closure device guides 5mm and 10/12 mm — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Retrieval Pouch (Multi Deploy) 15mm — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Advanced Endodontic System — ASI MEDICAL, INC. · U
- neoClose 2 AutoAnchor Pack US — Neosurgical, Ltd. · Class II
- Lap Port Closure Device Bariatric Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Trocar Swab Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Lap-port closure device guides 10/12mm and 15 mm Bariatric — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Cleared under the same submission
K980123 also covers:
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason — CooperSurgical, Inc.
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason CloseSure System — CooperSurgical, Inc.
- Carter-Thomason CloseSure System Pilot Guides — CooperSurgical, Inc.
- Carter-Thomason CloseSure System® — CooperSurgical, Inc.
- Carter-Thomason CloseSure System® (REGARD Distributed) — CooperSurgical, Inc.
- Carter-Thomason II — CooperSurgical, Inc.
- Carter-Thomason II Port Closure System — CooperSurgical, Inc.
- Carter-Thomason SG — CooperSurgical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (3)
- FDA UDI 67ae1999-0726-403d-a9b5-31ae9f3d1eb3 34 fields · synced Jul 13, 2026
- FDA UDI 9cc0a8f0-4b01-4787-a9b0-182793a0d250 34 fields · synced May 29, 2026
- EUDAMED 063ad1c9-808e-4119-bc2c-a316ea93f8c2 61 fields · synced Jul 13, 2026