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Carter-Thomason SG XL
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CTXL-SGModel CTI-1012P
Identity
- Trade Name
- Carter-Thomason® SureGrasp Suture Passer EUDAMEDCarter-Thomason SG XL FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- Carter-Thomason II Port Closure System™ EUDAMEDContents: One SureGrasp Suture Passer, one 10/12mm XL Pilot Guide and one 15mm XL Pilot Guide FDA UDI
- Model / Reference
- CTXL-SG EUDAMEDFDA UDICTI-1012P EUDAMED
- Description
- Contents: One SureGrasp Suture Passer, one 10/12mm XL Pilot Guide and one 15mm XL Pilot Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937002982 EUDAMEDFDA 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
No
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 SG XL 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 II Port Closure System — 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 (2)
- FDA UDI 3439d601-3d38-4980-b2e5-fcfa4ff1be97 34 fields · synced Jul 28, 2026
- EUDAMED 63417b55-4953-4682-83a8-8398644fa266 61 fields · synced Jul 28, 2026