MEDSUN - BYY4 28G
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QRK
Device Name: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class: 2
Physical State: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base.
Definition: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Used to puncture the skin.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Skin.
Regulation Number: 878.4850
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 16934047902434
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 06934047902437
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A