Duns Number:507185952
Catalog Number
-
Brand Name
Laparoscope
Version/Model Number
162 053 150
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945266
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
f4f415ed-4899-4b74-abf2-d2335107b3f1
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |