Medlance, safety lancet

Basic Information

• Brand Name: Medlance, safety lancet
• Primary DI: 05907506237044
• Version / Model: 1.5mm 1.0mm
• Catalog Number: 7003
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2020-08-15
• Public Version: 3
• Public Version Date: 2021-08-13
• Public Version Status: Update
• Public Device Record Key: 214cac95-7d2a-487f-94d5-470394d4beff

Device Description

Medlance, safety lancets are sterile, single use medical devices intended for capillary blood sampling.

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: Yes
• 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
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
Package	15907506237041	GS1	case	6	In Commercial Distribution
Primary	05907506237044	GS1
Unit of Use	85907506237040	GS1
Package	25907506237048	GS1	shipper	4	In Commercial Distribution

Customer Contacts

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