Duns Number:264205501
Device Description: This device is designed to create pneumoperitoneum (distension of the abdomen with CO2 gas This device is designed to create pneumoperitoneum (distension of the abdomen with CO2 gas) as part of a diagnostic and/or operative laparoscopy procedure.
Catalog Number
S_640_2004
Brand Name
COMEG MEDICAL
Version/Model Number
INSUFFLATEUR 20L SOPRO V3 CORDON US
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
K070783
Product Code
HIF
Product Code Name
Insufflator, Laparoscopic
Public Device Record Key
b5600b04-74ef-4f76-b24f-9b097e65c2c6
Public Version Date
December 20, 2018
Public Version Number
1
DI Record Publish Date
November 19, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |