Identity
- Trade Name
- CORE DYNAMICS FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- 7/8mm x 90mm Entree Plus Trocar, Reusable FDA UDI
- Model / Reference
- CD5080P-I FDA UDI
- Description
- 7/8mm x 90mm Entree Plus Trocar, Reusable FDA UDI
Identifiers
- Catalog Number
- CD5080P-I FDA UDI
- Primary DI / UDI-DI
- 30653405050173 FDA UDI
- 510(k) Number
- K950457 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Laparoscopic trocar blade, 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Millimeter 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 2d6f87c9-44da-4e66-8987-31c75457c92a 38 fields · synced May 31, 2026