Harmonic HARHD36

GUDID 20705036015052

HARMONIC HD 1000i Shears, 36cm Shaft Length

ETHICON ENDO-SURGERY, LLC

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

• Primary Device ID: 20705036015052
• NIH Device Record Key: ae806b8e-dc47-4071-ae27-4eb7bc9b42ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmonic
• Version Model Number: HARHD36
• Catalog Number: HARHD36
• 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 -22 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036015055 [Unit of Use]
GS1	20705036015052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160752

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

[20705036015052]

Ethylene Oxide

[20705036015052]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

On-Brand Devices [Harmonic]

• 20705036015052: HARMONIC HD 1000i Shears, 36cm Shaft Length
• 20705036015045: HARMONIC HD 1000i Shears, 20cm Shaft Length
• 30705036014731: HS FOCUS 17 CM PLUS ADAPTIVE
• 10705036013990: Harmonic Generator Connector
• 10705036012627: Harmonic Sterilization Tray
• 30705036011938: Harmonic Disposable Hand Switching Adaptors
• 10705036003274: Harmonic Blue Test Tip for use with Blue Hand Piece Only
• 30705036003117: Harmonic Torque Lock Blade Wrench
• 10705036002192: Harmonic Test Tip
• 30705036002172: Harmonic 5mm Adaptor
• 10705036002154: Harmonic Blue Hand Piece and Blue Test Point
• 10705036002147: Harmonic Hand Piece
• 30705036002127: Harmonic Combination Hook Blades 10mm
• 30705036002097: Harmonic Curved Blades 5mm
• 30705036001632: Harmonic Dissecting Hooks with Protective Sleeves-10cm
• 10705036015055: HARMONIC HD 1000i Shears, 36cm Shaft Length
• 10705036015048: HARMONIC HD 1000i Shears, 20cm Shaft Length
• 20705036026171: HARMONIC 1100 Shears, 20cm Shaft Length
• 20705036026164: HARMONIC 1100 Shears, 36cm Shaft Length
• 30705036023443: HARMONIC BLUE HAND PIECE
• 30705036023429: HARMONIC GREY HAND PIECE
• 20705036015489: ENSEAL X1 STRAIGHT 37CM SHAFT
• 20705036015458: ENSEAL X1 STRAIGHT 25CM SHAFT
• 20705036035784: Harmonic 700 Shears, Advanced Hemostasis
• 20705036035777: Harmonic 700 Shears, Advanced Hemostasis
• 20705036035760: Harmonic 700 Shears, Advanced Hemostasis