Medlance, safety lancet

Basic Information

• Brand Name: Medlance, safety lancet
• Primary DI: 05907996095483
• Version / Model: 28G 1.8mm
• Catalog Number: 7007
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2021-08-12
• Public Version: 1
• Public Version Date: 2021-08-20
• Public Version Status: New
• Public Device Record Key: a3f35226-e74f-4704-8192-1f1255705d63

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	15907996095480	GS1	case	6	In Commercial Distribution
Primary	05907996095483	GS1
Package	25907996095487	GS1	shipper	4	In Commercial Distribution
Unit of Use	85907996095489	GS1

Customer Contacts

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