Needle, Air Aspirator 16 Ga W/Blue Cap

FDA UDI

Class I (US FDA UDI)

by Novosci Corp.

Identity

Trade Name: NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. FDA UDI
Model / Reference: 201005NS FDA UDI
Description: A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. FDA UDI

Identifiers

Catalog Number: 201005NS FDA UDI
Primary DI / UDI-DI: B066201005NS1 FDA UDI
510(k) Number: K801393 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Body aspiration needle, single-use 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Body aspiration needle, single-use

Needle, Air Aspirator 16 Ga W/Blue Cap by Novosci Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body aspiration needle, single-use.

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COMPLETE-CHIBA MR — STERYLAB SRL · Class II
Invivo — Philips DS North America LLC · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · Class II

Cleared under the same submission

K801393 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: Novosci Corp.

Sources (1)

FDA UDI 1e8cf624-e0d8-4088-9ff5-4041893d3579 36 fields · synced May 30, 2026