Duns Number:131489882
Device Description: DESTINATION Renal Guiding Sheath
Catalog Number
54-54505
Brand Name
DESTINATION
Version/Model Number
54-54505
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 19, 2022
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
22bb8cda-6e0d-4292-a887-02c10655a3d1
Public Version Date
May 25, 2022
Public Version Number
10
DI Record Publish Date
September 24, 2016
Package DI Number
50389701008955
Quantity per Package
10
Contains DI Package
00389701008950
Package Discontinue Date
May 19, 2022
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| 3 | A medical device with high risk that requires premarket approval | 4 |