Duns Number:079940465
Device Description: NEURO-PULSE™ SURGICAL NERVE LOCATOR (YELLOW LED)
Catalog Number
0003Y
Brand Name
Bovie
Version/Model Number
0003Y
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Yes
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
-
Product Code
ETN
Product Code Name
Stimulator, Nerve
Public Device Record Key
fe0d33e7-974b-4f55-8388-49bbb536b304
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
October 13, 2016
Package DI Number
10607151002272
Quantity per Package
10
Contains DI Package
00607151002275
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 433 |