Duns Number:144998551
Device Description: The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patien The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together.
Catalog Number
2404
Brand Name
Model 2404 Maestro Patient Kit
Version/Model Number
2404
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P130019
Product Code
PIM
Product Code Name
neuromodulator for obesity
Public Device Record Key
f3155d2d-535e-4238-b02d-25933379e118
Public Version Date
September 21, 2020
Public Version Number
5
DI Record Publish Date
April 17, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 20 |