Harmonic HPBLUE

GUDID 10705036002154

Harmonic Blue Hand Piece and Blue Test Point

ETHICON ENDO-SURGERY, LLC

Soft-tissue ultrasonic surgical system handpiece, hand-controlled, reusable

• Primary Device ID: 10705036002154
• NIH Device Record Key: 7a36fa7a-102a-40d7-8631-d50dd3e48d07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmonic
• Version Model Number: HPBLUE
• Catalog Number: HPBLUE
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• 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 -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036002154 [Direct Marking]
GS1	20705036002151 [Primary]
GS1	30705036002158 [Package]; Contains: 20705036002151; Package: CASE [27 Units]; In Commercial Distribution

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705036002154]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-15

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• 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