Identity
- Trade Name
- CORE DYNAMICS FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 10/12MM CORE AUDIBLE DILATING TROCAR FDA UDI
- Model / Reference
- CD7100G FDA UDI
- Description
- 10/12MM CORE AUDIBLE DILATING TROCAR FDA UDI
Identifiers
- Catalog Number
- CD7100G FDA UDI
- Primary DI / UDI-DI
- 20653405046001 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
- Outer Diameter — 5 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.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Aligned Medical Solutions — Aligned Medical Solutions · 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
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI 8a873f5a-9484-4328-b9da-8c21c4d6824f 37 fields · synced May 30, 2026