US DIAGNOSTICS Pen Needles, 31G x 5MM

FDA UDI

Class II (US FDA UDI)

by Yidobio, Inc.

Identity

Trade Name: US DIAGNOSTICS Pen Needles, 31G x 5MM FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables. FDA UDI
Model / Reference: 100091 FDA UDI
Description: US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857513006278 FDA UDI
510(k) Number: K160575 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

FDA UDI

Over-the-Counter

Yes

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

Dimensions & Sizes

Size: Needle Gauge — 31 Gauge FDA UDI
Length — 5 Millimeter FDA UDI

Category: Autoinjector needle

US DIAGNOSTICS Pen Needles, 31G x 5MM by Yidobio, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autoinjector needle.

Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
MICRON, droplet pen needle — HTL STREFA S A · Class II
SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
droplet®, pen needles — HTL STREFA S A · Class II
Nano 2nd Gen — embecta Medical II LLC · Class II
BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II

Cleared under the same submission

K160575 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Yidobio, Inc.

Sources (1)

FDA UDI 8653467d-3ec8-4747-8377-056d7cb7f371 35 fields · synced May 30, 2026