Duns Number:196548481
Device Description: Neptune E-SEP Smoke Evacuation Pencil, Push Button, Coated, Bulk Non-Sterile
Catalog Number
0703-046-002
Brand Name
Neptune E-SEP
Version/Model Number
0703046002
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
9e8b3cb9-455c-4a28-a209-a8bb9167fe80
Public Version Date
February 22, 2021
Public Version Number
4
DI Record Publish Date
July 12, 2017
Package DI Number
37613327379489
Quantity per Package
10
Contains DI Package
07613327379488
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |