Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for assisted blood drawn by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Assure Lance Safety Lancets 28g 30ct. Single
Assure® Lance Safety Lancets - 980328

A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 single-use device.

• Needle Gauge: 28 Gauge

Device Sterile: True

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: 10015482983281

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00015482983284

Package Quantity: 60

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case Shipper

Device Id: 00015482983284

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: 50015482983289

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