Harmonic Ace ACE45E

GUDID 30705036000970

Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench

ETHICON ENDO-SURGERY, LLC

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

• Primary Device ID: 30705036000970
• NIH Device Record Key: 86c6c731-8462-4d58-9c49-e8433b73ac3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmonic Ace
• Version Model Number: ACE45E
• Catalog Number: ACE45E
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036000976 [Unit of Use]
GS1	20705036000973 [Primary]
GS1	30705036000970 [Package]; Contains: 20705036000973; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132522

FDA Product Code

• LFL: Instrument, ultrasonic surgical

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 Ace]

• 40705036014677: Harmonic ACE +7 Shears Advanced Hemostasis 5mm Diameter 23cm Shaft length For Use With Gray Han
• 40705036014639: Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use
• 40705036014622: Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 36cm Shaft length For Use
• 30705036014441: Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Gen
• 30705036014434: Harmonic Ace 5mm Diameter Shears 23cm Shaft length + Adaptive Tissue Technology for use with Gen
• 30705036000970: Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
• 30705036000932: Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
• 30705036000895: Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
• 30705036000888: Harmonic Ace Curved Shears with Scissor Handle and Hand Control