Duns Number:131489882
Device Description: DESTINATION Peripheral Guiding Sheath
Catalog Number
54-74506
Brand Name
DESTINATION
Version/Model Number
54-74506
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
7476939a-e29c-40d1-b988-2f8a4f840f0e
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
50389701008863
Quantity per Package
10
Contains DI Package
00389701008868
Package Discontinue Date
-
Package Status
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 |