Duns Number:149818952
Device Description: Endomyocardial Biopsy Forceps
Catalog Number
408297
Brand Name
Procure™
Version/Model Number
408297
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
K991486
Product Code
DWZ
Product Code Name
DEVICE, BIOPSY, ENDOMYOCARDIAL
Public Device Record Key
7d5c5f8c-8d8f-4343-8e0d-6e5e4391cf70
Public Version Date
July 08, 2019
Public Version Number
3
DI Record Publish Date
April 20, 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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |