Identity
- Trade Name
- CORE DYNAMICS FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 10mm x 150mm Entree II Cannula and Trocar, Reusable FDA UDI
- Model / Reference
- CD1526 FDA UDI
- Description
- 10mm x 150mm Entree II Cannula and Trocar, Reusable FDA UDI
Identifiers
- Catalog Number
- CD1526 FDA UDI
- Primary DI / UDI-DI
- 20653405044908 FDA UDI
- 510(k) Number
- K950457 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Core Dynamics by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 4a1d4c9d-8e57-499e-aa10-4ee91da789f5 38 fields · synced Jun 1, 2026