Duns Number:044606982
Device Description: Enseal Laparoscopic Tissue Sealer G2 Curved Jaw for use with G2 Generator 5mm Diameter 45c Enseal Laparoscopic Tissue Sealer G2 Curved Jaw for use with G2 Generator 5mm Diameter 45cm Shaft length
Catalog Number
NSLG2C45
Brand Name
Enseal
Version/Model Number
NSLG2C45
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
97122bfc-7804-4d90-9dc3-2c24e51264cd
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
20705036014154
Quantity per Package
6
Contains DI Package
10705036014157
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 |