Duns Number:688256864
Device Description: 15.7mm/13.3mm
Catalog Number
-
Brand Name
ClearCap Distal Attachment
Version/Model Number
FM-EC0007
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"
Yes
For Single-Use
Yes
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
K202616,K202616,K202616
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
bf1a4f7e-3dde-45ef-a41b-c25536573992
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 11, 2021
Package DI Number
18809327350633
Quantity per Package
10
Contains DI Package
08809327350636
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |