Duns Number:022672652
Device Description: Support Catheter, 180 cm working length, compatible with 0.018" guidewires
Catalog Number
CAM-018-180
Brand Name
Camaro Support Catheter
Version/Model Number
CAM-018-180
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
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
3dc490ae-f7be-4e42-b7cd-a950e98528ae
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
July 14, 2020
Package DI Number
00853892004348
Quantity per Package
5
Contains DI Package
00853892004195
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |