Sterilance Flex3 Depth Adjustable Safety Lancet

Basic Information

• Brand Name: Sterilance Flex3 Depth Adjustable Safety Lancet
• Primary DI: 16945630109017
• Version / Model: 05-1526A
• Company Name: SteriLance Medical (Suzhou) Inc.
• Labeler DUNS: 421141183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-12-21
• Public Version: 1
• Public Version Date: 2020-12-29
• Public Version Status: New
• Public Device Record Key: 200735e5-8864-4003-8309-02d26233bda0

Device Description

Sterilance Flex3 Depth Adjustable Safety Lancet,26G 1.3mm/1.8mm/2.3mm,100Lancets/box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
61578	Manual blood lancing device, single-use	A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06945630109010	GS1
Primary	16945630109017	GS1