Embrace Safety Lancet

Basic Information

• Brand Name: Embrace Safety Lancet
• Primary DI: 00894030002659
• Version / Model: SHN02GX30.18
• Company Name: OMNIS HEALTH, LLC
• Labeler DUNS: 824763358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-05
• Public Version: 1
• Public Version Date: 2021-07-13
• Public Version Status: New
• Public Device Record Key: 918eab33-c0e6-4475-8b60-fedddbd06de2

Device Description

Embrace Safety Lancet 30G/1.8mm 100ct.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMK	Lancet, Blood	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894030002659	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge
Length	1.8	Millimeter