Duns Number:076769355
Device Description: A flexible manual device used in combination with a compatible endoscope to grasp foreign A flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with a helical shaped basket which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.
Catalog Number
4830
Brand Name
Hobbs Helical Retrieval Basket
Version/Model Number
4830
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
OCZ
Product Code Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Public Device Record Key
e7e7ba5a-fc63-4ba3-a654-49b06ceb674a
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |