Duns Number:401020409
Device Description: The Locking device is an adapter for holding and securing the position of a device with an The Locking device is an adapter for holding and securing the position of a device with an outside diameter of 2-3 Fr that is inserted through a device with demale luer connector used during interventional of diagnostic procedures.
Catalog Number
RCG10992ST162
Brand Name
Locking device
Version/Model Number
RCG10992ST162
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGZ
Product Code Name
Accessories, Catheter
Public Device Record Key
57bed72b-0e46-4a9f-b4d2-2d6e682cc5f7
Public Version Date
September 02, 2019
Public Version Number
1
DI Record Publish Date
August 23, 2019
Package DI Number
03700512925514
Quantity per Package
16
Contains DI Package
03700512915515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box 2
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |