ergoLance, safety lancet

Basic Information

• Brand Name: ergoLance, safety lancet
• Primary DI: 05907996091393
• Version / Model: 21G 2.0mm
• Catalog Number: 8483
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 2
• Public Version Date: 2021-06-07
• Public Version Status: Update
• Public Device Record Key: d3e0d47c-a730-4a40-a296-c148fde63d9a

Device Description

ErgoLance, 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): Yes
• 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	15907996091390	GS1	shipper	20	In Commercial Distribution
Primary	05907996091393	GS1
Unit of Use	85907996091399	GS1

Customer Contacts

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