Duns Number:044606982
Device Description: Bariatric Laparoscopic Sleeve Gastrectomy kit
Catalog Number
BX33
Brand Name
N/A
Version/Model Number
BX33
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
-
Product Code Name
-
Public Device Record Key
fd363f56-83c7-4826-ae68-80540a0bf345
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
June 06, 2017
Package DI Number
20705036015809
Quantity per Package
4
Contains DI Package
10705036015802
Package Discontinue Date
-
Package Status
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |