Duns Number:144998551
Device Description: The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory th The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding the Patient Transmit Coil over the location of the implanted Rechargeable Neuroregulator during charging.
Catalog Number
1660
Brand Name
Model 1660 Maestro Patient Transmit Coil Belt
Version/Model Number
1660
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
9336bfba-cd20-445c-a3fa-b6adc1ffdcd4
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 |