Identity
- Trade Name
- CORE DYNAMICS FDA UDI
- Generic Name
- Laparoscopic access cannula seal reducer, single-use FDA UDI
- Device Name
- 10/11mmSealing Cap for Entree® Plus Cannula and Reducer Sleeves FDA UDI
- Model / Reference
- CD111 FDA UDI
- Description
- 10/11mmSealing Cap for Entree® Plus Cannula and Reducer Sleeves FDA UDI
Identifiers
- Catalog Number
- CD111 FDA UDI
- Primary DI / UDI-DI
- 20653405044533 FDA UDI
- 510(k) Number
- K911813 FDA UDI
- FDA Product Code
- FBM FDA UDI
- GMDN Term
- Laparoscopic access cannula seal reducer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5090 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
Category: Laparoscopic access cannula seal reducer, single-use
Core Dynamics by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K911813 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
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI dcfe5a25-ba1e-4dab-8480-ec6c73b5877f 36 fields · synced May 29, 2026