Biotronix HealthCare Syringes

FDA UDI

Class II (US FDA UDI)

by Biotronix Healthcare Industries Inc.

Identity

Trade Name: Biotronix HealthCare Syringes FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each FDA UDI
Model / Reference: GE12012 FDA UDI
Description: Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each FDA UDI

Identifiers

Catalog Number: GE12012 FDA UDI
Primary DI / UDI-DI: 00858835007202 FDA UDI
510(k) Number: K060211 FDA UDI
K222124 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
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

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: Hypodermic needle, single-use General-purpose syringe, single-use

Biotronix HealthCare Syringes by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

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SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

Cleared under the same submission

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: Biotronix Healthcare Industries Inc.

Sources (1)

FDA UDI ef262936-60bc-46e5-a641-0bf31255237f 37 fields · synced May 30, 2026