Embrace Safety Lancet

FDA UDI

Class II (US FDA UDI)

by Omnis Health, Llc

Identity

Trade Name: Embrace Safety Lancet FDA UDI
Generic Name: Blood lancet, single-use FDA UDI
Device Name: Embrace Safety Lancet 23G/1.8mm 100ct. FDA UDI
Model / Reference: SHN02GX23.18 FDA UDI
Description: Embrace Safety Lancet 23G/1.8mm 100ct. FDA UDI

Identifiers

Primary DI / UDI-DI: 00894030002673 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Blood lancet, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 23 Gauge FDA UDI
Length — 1.8 Millimeter FDA UDI

Category: Blood lancet, single-use

Embrace Safety Lancet by Omnis Health, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Omnis Health, Llc

Sources (1)

FDA UDI 96e23587-bb3d-4b55-b139-d5399adc8876 34 fields · synced May 31, 2026