Duns Number:627969264
Device Description: CO2 Hose and DIN for use with Laparoscopic insufflators
Catalog Number
-
Brand Name
CO2 Hose and DIN
Version/Model Number
7-510-36
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K022052
Product Code
HIF
Product Code Name
Insufflator, Laparoscopic
Public Device Record Key
5f898022-881d-40e9-ad6f-129b213db4ad
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
October 14, 2016
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. | 54 |