Duns Number:044606982
Device Description: Enseal Tissue Sealer G2 Super Jaw curved for use with Generator G11 22cm Shaft length
Catalog Number
NSEALX22L
Brand Name
Enseal
Version/Model Number
NSEALX22L
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
a6f5d75d-a2e3-447d-bbe6-76c9e83dfab0
Public Version Date
October 16, 2019
Public Version Number
5
DI Record Publish Date
July 15, 2016
Package DI Number
20705036013805
Quantity per Package
6
Contains DI Package
10705036013808
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |