FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Model 2004 Maestro Implant Kit
DI: 00857334004279
·
Model: 2004
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model 2004 Maestro Implant Kit
- Primary DI
- 00857334004279
- Version / Model
- 2004
- Catalog Number
- 2004
- 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
- 400d27b0-6ca3-4a98-a54f-6d5769a6f9a3
- Distribution End Date
- 2019-06-01
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857334004279 | GS1 |
Customer Contacts
- Phone
- +1(651)789-2681
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130019 | 000 |
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