Identity
- Trade Name
- CORE DYNAMICS FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Trocar Procedure Kit, Lap Chole FDA UDI
- Model / Reference
- CD7435G FDA UDI
- Description
- Trocar Procedure Kit, Lap Chole FDA UDI
Identifiers
- Catalog Number
- CD7435G FDA UDI
- Primary DI / UDI-DI
- 20653405046094 FDA UDI
- 510(k) Number
- K992250 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 110 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Category: Laparoscopic surgical procedure kit, non-medicated, single-use
Core Dynamics by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic surgical procedure kit, non-medicated, single-use.
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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Cleared under the same submission
K992250 also covers:
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
- CORE DYNAMICS — Conmed Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI e60f1d8b-e01f-4da5-aaf8-b3f2a29fa399 37 fields · synced Jun 6, 2026