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Manan Gwi Guide Wire Introducermanan Gwi Guide Wire Introducer
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 21GA X 4CM ECHO TIP21GA X 4CM EC NEEDLENEEDLE FDA UDI
- Model / Reference
- MC214 FDA UDI
- Description
- 21GA X 4CM ECHO TIP21GA X 4CM EC NEEDLENEEDLE FDA UDI
Identifiers
- Catalog Number
- MC214 FDA UDI
- Primary DI / UDI-DI
- 00884908028782 FDA UDI
- 510(k) Number
- K851834 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
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
Category: Vascular catheter introduction needle
Manan Gwi Guide Wire Introducermanan Gwi Guide Wire Introducer by Medical Components Inc — Class I — FDA UDI — listed in FDA GUDID
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- Cook — COOK INCORPORATED · Class II
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- BD Potts-Cournand 18Gx2.05in — BECTON DICKINSON AND COMPANY · Class II
- Procedure Products needles — PROCEDURE PRODUCTS, INC. · Class II
Cleared under the same submission
K851834 also covers:
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
- Medical Components Inc
Sources (1)
- FDA UDI a37a4fd9-19a9-471e-8577-0e3f72800a41 36 fields · synced May 30, 2026