Duns Number:627879687
Device Description: The Baleen polyp trap is a single use device used in the suction retrieval of endoscopical The Baleen polyp trap is a single use device used in the suction retrieval of endoscopically removed polyps.
Catalog Number
NBPT520
Brand Name
Baleen
Version/Model Number
NBPT520
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
5a00d775-3d06-4ded-9c75-2bfe4999f0b8
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
August 23, 2018
Package DI Number
20816765014398
Quantity per Package
5
Contains DI Package
10816765014391
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |