Identity
- Trade Name
- Carter-Thomason CloseSure System™ EUDAMEDCarter-Thomason FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Carter-Thomason II Port Closure System™ EUDAMEDCloseSure System Suture Passer FDA UDI
- Model / Reference
- CTI-SP EUDAMEDFDA UDICTI-1012P EUDAMED
- Description
- CloseSure System Suture Passer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002942 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
- Suturing unit, single-use 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: Suturing unit, single-use
Carter-Thomason by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
- eXact 5.1 — Cypris Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- 25° Left, Champion®+ Slider with Nitinol Passing Wire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K980123 also covers:
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 9715b9d9-bbed-4959-a4fa-5875d187bf92 34 fields · synced Jun 19, 2026
- EUDAMED 9656ef15-f632-4267-93ad-967b45943497 61 fields · synced Jun 19, 2026