microdot®

Basic Information

• Brand Name: microdot®
• Primary DI: 00847713000084
• Version / Model: 528-28
• Company Name: Cambridge Sensors USA LLC
• Labeler DUNS: 962314360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2023-01-10
• Public Version: 1
• Public Version Date: 2023-01-18
• Public Version Status: New
• Public Device Record Key: e7b97b99-0c81-406c-b0ae-ba80ec6b52e5

Device Description

28g /1.8mm Pressure Activated Safety Lancet (Box of 200 lancets)

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: Yes
• 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	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	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	00847713000084	GS1
Package	00847713000213	GS1	Case	24	In Commercial Distribution
Unit of Use	00847713000343	GS1

Premarket Submissions

Submission Number	Supplement Number
K222376	000