Duns Number:927071162
Device Description: EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
EvBNHT-10
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
K092732,K143103,K092732,K143103,K092732,K143103
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f6f1bc70-728c-4a57-a7a2-fa0dfa87202d
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
20817325022990
Quantity per Package
4
Contains DI Package
10817325022993
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |