Duns Number:024230633
Device Description: Retic-Count Upgrade Version 1.1
Catalog Number
343173
Brand Name
BD Retic-Count™
Version/Model Number
343173
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K880636
Product Code
GKL
Product Code Name
COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
Public Device Record Key
9fd19b1e-c2ac-4b0c-b37b-44da28cc7e0e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 08, 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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |