AccessGUDID - DEVICE: Model 2004 Maestro Implant Kit (00857334004279)

GUDID

Device Identifier (DI) Information

Brand Name: Model 2004 Maestro Implant Kit
Version or Model: 2004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2004
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004279
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 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together.

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:	Yes
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?
47659	Gastric contractility modulation system	An assembly of devices designed to improve glycaemic control and induce weight loss in obese patients with type 2 diabetes mellitus by monitoring intrinsic electrical and mechanical gastric activity and delivering gastric contractility modulation (GCM) signals to the stomach to provoke an early response of a full meal. It typically includes a battery-powered implantable pulse generator that produces GCM electrical stimuli delivered via implantable leads, an external programmer that enables healthcare personnel to telemetrically modify the GCM signal parameters of the pulse generator, an external charger to recharge the pulse-generator battery, a shadow data recorder, and a patient wand.	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
No Device Sizes

Device Record Status

Public Device Record Key: 400d27b0-6ca3-4a98-a54f-6d5769a6f9a3
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: April 17, 2015