AccessGUDID - DEVICE: Model 1680 Torque Wrench (00857334004248)

GUDID

Device Identifier (DI) Information

Brand Name: Model 1680 Torque Wrench
Version or Model: 1680
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1680
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004248
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 144998551 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIM	neuromodulator for obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130019	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 1.685 Inch
Outer Diameter: 0.218 Inch

Device Record Status

Public Device Record Key: b4849c40-160c-448f-944e-350a3a511f32
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: April 17, 2015