Duns Number:338664915
Device Description: Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
Catalog Number
10551
Brand Name
Connector for silicone Fr 19
Version/Model Number
10551
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCD
Product Code Name
Connector, Catheter
Public Device Record Key
8e103652-5fca-4f8d-be5a-66f84022a123
Public Version Date
May 19, 2021
Public Version Number
1
DI Record Publish Date
May 11, 2021
Package DI Number
18034139297030
Quantity per Package
50
Contains DI Package
08034139297033
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 | 105 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |