Duns Number:044606982
Device Description: Enseal Temperature Controlled Tissue Sealing Technology Disposable Tissue Sealing Device T Enseal Temperature Controlled Tissue Sealing Technology Disposable Tissue Sealing Device Taptronic Trigger Activated Power 5mm Jaw Style
Catalog Number
NSEAL535RH
Brand Name
Enseal
Version/Model Number
NSEAL535RH
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
dfa04039-fa1d-4a9d-8d85-7c0bb589c399
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
20705036000041
Quantity per Package
6
Contains DI Package
10705036000044
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 |