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Manan Gwi Guide Wire Introducermanan Gwi Guide Wire Introducer

FDA UDI

Class I (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER FDA UDI
Generic Name
Vascular catheter introduction needle FDA UDI
Device Name
22GA X 1.5" (3.8CM)22GA X 1.5" ( INTRODUCER NEEDLEINTRODUCER NEED FDA UDI
Model / Reference
MC224 FDA UDI
Description
22GA X 1.5" (3.8CM)22GA X 1.5" ( INTRODUCER NEEDLEINTRODUCER NEED FDA UDI

Identifiers

Primary DI / UDI-DI
00884908105285 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
Not 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

Manan Gwi Guide Wire Introducermanan Gwi Guide Wire Introducer by Medical Components Inc — Class I — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K851834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 00839ad7-8d4e-4539-a05f-04826c08b9f4 36 fields · synced Jun 1, 2026