Duns Number:627969264
Catalog Number
72-00328-0
Brand Name
Adapter for Hoses
Version/Model Number
7204275
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
K022052,K022052
Product Code
HIF
Product Code Name
Insufflator, Laparoscopic
Public Device Record Key
26ad37b7-cd03-4202-a8c4-1370fd5ed08f
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 07, 2020
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 |