Duns Number:021717889
Device Description: Locking Device and Biopsy Cap For Use with RX Biliary System
Catalog Number
-
Brand Name
RX Locking Device and Biopsy Cap
Version/Model Number
M00545280
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
ODC
Product Code Name
Endoscope channel accessory
Public Device Record Key
290f8fa3-adf9-4bad-9a61-2f968533b600
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
08714729296638
Quantity per Package
10
Contains DI Package
08714729746690
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |