Harmonic LaparaSonic HBC05

GUDID 30705036002066

Harmonic LaparaSonic Ball Coagulators 5mm

ETHICON ENDO-SURGERY, LLC

Soft-tissue ultrasonic surgical system handpiece tip, single-use Soft-tissue ultrasonic surgical system handpiece tip, single-use

• Primary Device ID: 30705036002066
• NIH Device Record Key: c89a304c-3f90-434b-b44c-3c53c930bb4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmonic LaparaSonic
• Version Model Number: HBC05
• Catalog Number: HBC05
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036002062 [Unit of Use]
GS1	20705036002069 [Primary]
GS1	30705036002066 [Package]; Contains: 20705036002069; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962584

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [Harmonic LaparaSonic]

• 30705036002103: Harmonic LaparaSonic Dissecting Hooks 5mm
• 30705036002066: Harmonic LaparaSonic Ball Coagulators 5mm