MEDSUN - XY1 Blade 1.2mm
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: FMK
Device Name: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class: 2
Physical State: A single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature).
Definition: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Device used to puncture 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: 16934047902410
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: 06934047902413
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