Unilet ComforTouch 30G Super Thin Lancets 100 count
Unilet ComforTouch - AT 0465
Device Description
A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Needle Gauge: 30 Gauge
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: 00384700465032
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00384700465018
Package Quantity: 200
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00384700465018
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: 00384700465001
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