TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling.
TechLITE® Lancets, 28g - 880128
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: 28 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QRL
Device Name: Multiple Use Blood Lancet For Single Patient Use Only
Device Class: 2
Physical State: Comprised of a single use blade attached to a solid, reusable base.
Definition: A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable 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 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 Identifiers
Device Id: 00015482880187
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: 50015482880182
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
Device Id: 10015482880184
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00015482880187
Package Quantity: 24
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case Pack
Device Id: 20015482880181
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10015482880184
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Master Shipper