Duns Number:071595540
Device Description: Laparoscope 30° 30 cm x 3.3 mm, includes light cable adapters
Catalog Number
LIL-33-30
Brand Name
MICROLAP
Version/Model Number
LIL-33-30
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2021
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,K941541
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0924a198-d42a-4c17-8594-1382b8c0485c
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
April 03, 2017
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |