FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Model 2002 Maestro Rechargeable Neuroregulator
DI: 00857334004262
·
Model: 2002
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model 2002 Maestro Rechargeable Neuroregulator
- Primary DI
- 00857334004262
- Version / Model
- 2002
- Catalog Number
- 2002
- 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
- e8b659cd-a553-4204-8ae6-c5f161779c3c
- Distribution End Date
- 2019-06-01
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857334004262 | GS1 |
Customer Contacts
- Phone
- +1(651)789-2681
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130019 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 86 | Millimeter | |
| Height | 16 | Millimeter | |
| Length | 71 | Millimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity