LiteTouch

FDA UDI

Class II (US FDA UDI)

by Amity Holdings, Llc

Identity

Trade Name: LiteTouch FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: MediCore's LiteTouch Luer Lock Hypodermic Syringe w/Needle FDA UDI
Model / Reference: 716LW FDA UDI
Description: MediCore's LiteTouch Luer Lock Hypodermic Syringe w/Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00732671071620 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

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: Length — 1.0 Inch FDA UDI
Needle Gauge — 23 Gauge FDA UDI
Total Volume — 3.0 Milliliter FDA UDI

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

LiteTouch by Amity Holdings, Llc — 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

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: Amity Holdings, Llc

Sources (1)

FDA UDI def74ae3-76ca-4aca-9537-cd4761771aba 35 fields · synced May 31, 2026