Duns Number:505942961
Device Description: The Distal Tip Soaker is designed to retain moisture around distal tips of complex instrum The Distal Tip Soaker is designed to retain moisture around distal tips of complex instruments and allow for easy cleaning.
Catalog Number
M20413
Brand Name
Distal Tip Soaker
Version/Model Number
Distal Duck
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLG
Product Code Name
Cleaner, ultrasonic, medical instrument
Public Device Record Key
6d8a308b-fda9-4270-b32d-23528b17ae05
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
55060247261879
Quantity per Package
6
Contains DI Package
15060247261871
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |