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Guidewire Introducer Needle

FDA UDI

Class I (US FDA UDI)

by Remington Medical, Inc.

Identity

Trade Name
Guidewire Introducer Needle FDA UDI
Generic Name
Intra-arterial needle FDA UDI
Device Name
18ga (1.3mm) x 7cm FDA UDI
Model / Reference
GWI-1802 FDA UDI
Description
18ga (1.3mm) x 7cm FDA UDI

Identifiers

Catalog Number
GWI-1802 FDA UDI
Primary DI / UDI-DI
00813079020301 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Intra-arterial 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 18 Gauge FDA UDI

Category: Intra-arterial needle

Guidewire Introducer Needle by Remington Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intra-arterial needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI bdb757e7-b585-4892-b73d-49ae9144991b 36 fields · synced Jun 8, 2026