Duns Number:627879687
Device Description: The disposable overtube is used in conjunction with a flexible endoscope for foreign body The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
Catalog Number
SI711148
Brand Name
Guardus
Version/Model Number
SI711148
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
K040836
Product Code
FED
Product Code Name
endoscopic access overtube, gastroenterology-urology
Public Device Record Key
08939296-3b45-4940-9fc3-c84fa27b1f99
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
September 17, 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |