Duns Number:530269083
Device Description: The product is used to collect tissue samples of the diameter larger than 1mm and can be d The product is used to collect tissue samples of the diameter larger than 1mm and can be drawn through the endoscope through the suction device, which can be used for pathological analysis.
Catalog Number
-
Brand Name
MT
Version/Model Number
BBP-50
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"
Yes
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
e9e53608-15cc-41eb-84b1-21f15a92e5eb
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
16932503554012
Quantity per Package
25
Contains DI Package
06932503554015
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |