Duns Number:044606982
Device Description: ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
Catalog Number
NSLX145C
Brand Name
Enseal
Version/Model Number
NSLX145C
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
K172580,K172580
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
4c7b11bc-5961-4844-be24-ae3740bfebcd
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 20, 2019
Package DI Number
20705036015496
Quantity per Package
3
Contains DI Package
10705036015499
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 |