Duns Number:482661753
Device Description: Laparoscope, High Definition Eye Piece style 10 mm x 45 DEGREES x 330 mm
Catalog Number
242637
Brand Name
NA
Version/Model Number
242637
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K941541
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
87e7c108-5bef-43ee-840a-455533e3ad3f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 22, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |