LiteTouch

FDA UDI

Class II (US FDA UDI)

by Amity Holdings, Llc

Identity

Trade Name: LiteTouch FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: MediCore's "LiteTouch Insulin Syringe FDA UDI
Model / Reference: 513 FDA UDI
Description: MediCore's "LiteTouch Insulin Syringe FDA UDI

Identifiers

Primary DI / UDI-DI: 10732671105131 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
GMDN Term: Insulin syringe/needle, basic 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: Total Volume — 1.0 Milliliter FDA UDI
Length — 12.7 Millimeter FDA UDI
Needle Gauge — 29 Gauge FDA UDI

Category: Insulin syringe/needle, basic

LiteTouch by Amity Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin syringe/needle, basic.

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Insulin Syringe — Dynarex Corp. · Class II
Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Insulin Syringe — Dynarex Corp. · 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: Amity Holdings, Llc

Sources (1)

FDA UDI 5dfe1326-8a09-4d70-b3d8-3fbe55baaece 35 fields · synced Jun 8, 2026