Pencil Point Spinal Needle

FDA UDI

Class II (US FDA UDI)

by Shanghai SA Medical & Plastic Instruments Co., Ltd.

Identity

Trade Name: Pencil Point Spinal Needle FDA UDI
Generic Name: Spinal needle, single-use FDA UDI
Device Name: 24G x 3 1/2" (90mm), sterile, with Introducer(20G*30mm) FDA UDI
Model / Reference: AN-S II FDA UDI
Description: 24G x 3 1/2" (90mm), sterile, with Introducer(20G*30mm) FDA UDI

Identifiers

Primary DI / UDI-DI: 06955741822340 FDA UDI
510(k) Number: K120475 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Spinal needle, single-use 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

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Spinal needle, single-use

Pencil Point Spinal Needle by Shanghai SA Medical & Plastic Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K120475 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: Shanghai SA Medical & Plastic Instruments Co., Ltd.

Sources (1)

FDA UDI 89c2aab1-4e2e-4068-940b-131eb6052116 35 fields · synced May 30, 2026