SAFETICET

Basic Information

• Brand Name: SAFETICET
• Primary DI: 08887629000213
• Version / Model: SC-220
• Company Name: NSP TECH PTE LTD
• Labeler DUNS: 653632729
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-20
• Public Version: 2
• Public Version Date: 2022-11-02
• Public Version Status: Update
• Public Device Record Key: 8e41a4a0-26ec-4a77-b04e-1dfb07ac24b9
• Distribution End Date: 2025-04-16

Device Description

Lancets are used to make punctures to obtain small blood specimens, are generally disposable, and are commonly used by diabetes patient. The small blood samples obtained can be tested for blood glucose, hemoglobin, and many other blood components. Lancets are also used to prick the skin in skin testing for allergies.

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

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
Package	08887629000244	GS1	box packaging	100	In Commercial Distribution	2025-04-16
Primary	08887629000213	GS1
Package	08887629000237	GS1	box packaging	50	In Commercial Distribution	2025-04-16
Package	08887629000220	GS1	box packaging	10	In Commercial Distribution	2025-04-16
Package	18887629000241	GS1	box packaging	20	In Commercial Distribution	2025-04-16
Package	18887629000234	GS1	box packaging	40	In Commercial Distribution	2025-04-16
Package	18887629000227	GS1	box packaging	200	In Commercial Distribution	2025-04-16

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Not exposed to direct sunlight