Duns Number:482661753
Device Description: REVIVE 044 intermediate catheter 121cm 4.1F (.054 Inch/1.37mm) I.D. 0.044 Inch (1.12mm) 11 REVIVE 044 intermediate catheter 121cm 4.1F (.054 Inch/1.37mm) I.D. 0.044 Inch (1.12mm) 115cm Contents: 1 Intermediate Catheter Minimum Guiding Catheter I.D. in./(mm) 0.060 Inch/(1.52mm)
Catalog Number
RC044115
Brand Name
REVIVE
Version/Model Number
RC044115
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2019
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
b0ec0569-e328-45f0-8d4b-8c79f6fdbd6b
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
June 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |