Unistik 3

Basic Information

• Brand Name: Unistik 3
• Primary DI: 00384701012013
• Version / Model: AT 1012
• Company Name: OWEN MUMFORD LIMITED
• Labeler DUNS: 217266915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-09-12
• Public Version: 3
• Public Version Date: 2023-02-02
• Public Version Status: Update
• Public Device Record Key: bac073d7-35f2-4dcb-b82d-a6c11610e1f0

Device Description

Unistik 3 Extra - 21G x 2.0mm, sterile, single use safety lancet

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: No
• 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
Package	00384701012037	GS1	Case	40	In Commercial Distribution
Primary	00384701012013	GS1
Unit of Use	00384701012006	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Depth	2.0	Millimeter
Needle Gauge	21	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius