AccessGUDID - DEVICE: Model 2002 Maestro Rechargeable Neuroregulator (00857334004262)

GUDID

Device Identifier (DI) Information

Brand Name: Model 2002 Maestro Rechargeable Neuroregulator
Version or Model: 2002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2002
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004262
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 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an integrated coil that acts as an antenna for telemetry and recharging. The RNR is surgically implanted to deliver electrical current to the implanted leads. It contains a rechargeable battery which is charged transcutaneously using a Transmit Coil.

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?
47664	Gastric contractility modulation system pulse generator	A hermetically-sealed, battery-powered device implanted beneath the skin and connected to implanted leads to monitor intrinsic electrical and mechanical gastric activity and deliver gastric contractility modulation (GCM) electrical signals to the stomach to help improve glycaemic control and induce weight loss typically in an obese patient with type 2 diabetes mellitus. The device is programmed by and transmits gastric diagnostic data to an external programmer telemetrically.	Active	true

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

Clinically Relevant Size

[?]

Size Type Text
Width: 86 Millimeter
Height: 16 Millimeter
Length: 71 Millimeter

Device Record Status

Public Device Record Key: e8b659cd-a553-4204-8ae6-c5f161779c3c
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: April 17, 2015