Duns Number:689850476
Catalog Number
N23-0575
Brand Name
Laport
Version/Model Number
N23-0575
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
K171741,K171741,K171741
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
fa23cc0c-1847-48c6-9776-0958dcf2fdca
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
April 05, 2018
Package DI Number
88806182210514
Quantity per Package
8
Contains DI Package
18806182210515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |