Duns Number:006261481
Device Description: CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
Catalog Number
-
Brand Name
Freezor® MAX
Version/Model Number
229F3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 15, 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
P020045
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
92b527f5-bbb0-4295-a66c-47cfb64d39c8
Public Version Date
June 12, 2019
Public Version Number
4
DI Record Publish Date
September 18, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |