Duns Number:829838288
Device Description: Handpiece 15 ga x 25 cm (MINOP)
Catalog Number
-
Brand Name
NICO Myriad
Version/Model Number
NN-8002
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
5cb46c44-7f0a-4533-bada-ae0bcb6c293a
Public Version Date
April 09, 2019
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
10816744028029
Quantity per Package
3
Contains DI Package
00816744028022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 40 |
2 | A medical device with a moderate to high risk that requires special controls. | 62 |