BD Ultra-Fine Pen Needles, 31G x 8MM (Sample)

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson Pen Limited

Identity

Trade Name: BD Ultra-Fine Pen Needles, 31G x 8MM (Sample) FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: PEN NDL 31GA 8MM 5BAG 500 SMP FDA UDI
Model / Reference: 320112 FDA UDI
Description: PEN NDL 31GA 8MM 5BAG 500 SMP FDA UDI

Identifiers

Catalog Number: 320112 FDA UDI
Primary DI / UDI-DI: 00382903201129 FDA UDI
510(k) Number: K131358 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

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

FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI
Needle Gauge — 31 Gauge FDA UDI

Category: Autoinjector needle

BD Ultra-Fine Pen Needles, 31G x 8MM (Sample) by Becton Dickinson Pen Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
ONE-CARE Pen Needles — MediVena, LLC · 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 II	Pending data

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Manufacturer

Manufacturer: Becton Dickinson Pen Limited

Sources (1)

FDA UDI 4de46747-6a19-4ae5-a451-bab53512665f 36 fields · synced Jun 8, 2026