SPpro GWI

FDA UDI

Class I (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name: SPpro GWI FDA UDI
Generic Name: Vascular catheter introduction needle FDA UDI
Device Name: 21ga x 7cm Sharps Safety Needle FDA UDI
Model / Reference: SPG-101-21-07 FDA UDI
Description: 21ga x 7cm Sharps Safety Needle FDA UDI

Identifiers

Catalog Number: SPG-101-21-07 FDA UDI
Primary DI / UDI-DI: B339SPG10127070 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 21 Gauge FDA UDI
Length — 7 Centimeter FDA UDI

Category: Vascular catheter introduction needle

SPpro GWI by Neo Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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: Neo Medical Inc.

Sources (1)

FDA UDI 8acc45b0-4e62-43c7-ac96-1bd85beff325 37 fields · synced May 30, 2026