SmartJet® Dual Liquid Applicator Kit, SK/S SmartJet Spray Applicator Kit

SmartJet® Dual Liquid Applicator Kit, SK/S SmartJet Spray Applicator Kit
HARVEST® SmartJet® - 51451

A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FMF

Device Name: Syringe, Piston

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5860

Third Party Flag: Y

Medical Specialty: HO

Device Id: 05020583514515

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: 35020583514516

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05020583514515

Package Quantity: 6

Package Discontinue Date: 2/14/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A