Duns Number:505280884
Device Description: Single-use Blade-Filter to be used with Microlyzer Cartridge
Catalog Number
BLD2400
Brand Name
MICROLYZER
Version/Model Number
BLADE-FILTER 2400
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
OJT
Product Code Name
Aspiration Tray
Public Device Record Key
3d054e75-e5b5-4bfa-a2c3-13b6ef19d1b5
Public Version Date
May 22, 2019
Public Version Number
1
DI Record Publish Date
May 14, 2019
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |