MSK Ultrasonic Injection Needle

FDA UDI

Class II (US FDA UDI)

by Spectra Medical Devices, LLC

Identity

Trade Name: MSK Ultrasonic Injection Needle FDA UDI
Generic Name: Peripheral nerve-block sharp needle FDA UDI
Device Name: 23G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Blue Hub, Lubricated, Molded Protector without Extension Set FDA UDI
Model / Reference: S80C23-2.00BL FDA UDI
Description: 23G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Blue Hub, Lubricated, Molded Protector without Extension Set FDA UDI

Identifiers

Primary DI / UDI-DI: M661S80C23200 FDA UDI
510(k) Number: K151069 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Peripheral nerve-block sharp needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5150 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peripheral nerve-block sharp needle

MSK Ultrasonic Injection Needle by Spectra Medical Devices, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral nerve-block sharp needle.

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SONO MSK — Pajunk GmbH Medizintechnologie · Class II
Temena — Te ME NA Sas · Class II
Temena — Te ME NA Sas · Class II
Temena — Te ME NA Sas · Class II
Spinal Needle — HAKKO CO., LTD. · Class II

Cleared under the same submission

K151069 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 II	Pending data

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Manufacturer

Manufacturer: Spectra Medical Devices, LLC

Sources (1)

FDA UDI dc08fd25-a494-4385-b1cc-40e595f43cc9 34 fields · synced Jun 9, 2026