DEVICE, LANCET (36/CS)

DEVICE, LANCET (36/CS)
Mckesson - 06-005

A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 40612479126372

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479126347

Package Quantity: 36

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20612479126347

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