Duns Number:005473608
Device Description: EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartri EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartridges
Catalog Number
137865
Brand Name
EXAlence™
Version/Model Number
137865
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2022
Issuing Agency
In HIBCC
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
-
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
K041398
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
a110df1c-7459-4496-998b-b7135e4c2f4d
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
August 01, 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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |