Duns Number:079720472
Device Description: Bronchoscope Cytology Brush
Catalog Number
BCB-5-120-3-S
Brand Name
Cook
Version/Model Number
G21386
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
FDX
Product Code Name
endoscopic cytology brush
Public Device Record Key
3bf643cd-2e30-46fe-84d1-455d8d1ebdec
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10827002213866
Quantity per Package
10
Contains DI Package
00827002213869
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |