Duns Number:825239189
Device Description: Endoscopic retrieval device, medium basket
Catalog Number
BGE-1622M
Brand Name
Elliptical Basket, Medium
Version/Model Number
BGE-1622M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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
K800970,K800970
Product Code
OCZ
Product Code Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Public Device Record Key
39f4ad2b-8891-4c47-b530-bc76b2d6ba10
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10816207020447
Quantity per Package
10
Contains DI Package
00816207020440
Package Discontinue Date
November 04, 2019
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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |