Model 1680 Torque Wrench 1680

GUDID 00857334004248

The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator.

ENTEROMEDICS INC.

Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable

• Primary Device ID: 00857334004248
• NIH Device Record Key: b4849c40-160c-448f-944e-350a3a511f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 1680 Torque Wrench
• Version Model Number: 1680
• Catalog Number: 1680
• Company DUNS: 144998551
• Company Name: ENTEROMEDICS INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com

Device Dimensions

• Outer Diameter: 0.218 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch
• Length: 1.685 Inch
• Outer Diameter: 0.218 Inch

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857334004248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130019

FDA Product Code

• PIM: neuromodulator for obesity

Sterilization

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

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

Ethylene Oxide

[00857334004248]

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: 2015-04-17

Devices Manufactured by ENTEROMEDICS INC.

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• 00857334004217 - Model 1660 Maestro Patient Transmit Coil Belt: 2018-07-06 The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding th
• 00857334004248 - Model 1680 Torque Wrench: 2018-07-06The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator.
• 00857334004248 - Model 1680 Torque Wrench: 2018-07-06 The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the
• 00857334004262 - Model 2002 Maestro Rechargeable Neuroregulator: 2018-07-06 The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an
• 00857334004279 - Model 2004 Maestro Implant Kit: 2018-07-06 The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 22
• 00857334004286 - Model 2200A-47E Maestro Anterior Lead: 2018-07-06 The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iri
• 00857334004293 - Model 2200P-47E Maestro Posterior Lead: 2018-07-06 The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/ir