Model 1680 Torque Wrench

Basic Information

• Brand Name: Model 1680 Torque Wrench
• Primary DI: 00857334004248
• Version / Model: 1680
• Catalog Number: 1680
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 144998551
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-17
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: b4849c40-160c-448f-944e-350a3a511f32
• Distribution End Date: 2019-06-01

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIM	neuromodulator for obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
32871	Surgical torque wrench, reusable	A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857334004248	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P130019	000

Device Sizes

Type	Value	Unit	Text
Length	1.685	Inch
Outer Diameter	0.218	Inch

Storage Conditions

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