Duns Number:690625850
Device Description: Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Flexible Overtube consists of an overtube with a coiled stainless steel skelton, a detachable seal unit for an endoscope, and a detachable mouthpiece for a patient. The steel skelton of the overtube prevents the overtube from being bent and collapsed while keeping flexibility of the overtube. The detachable seal unit named “AD rubber unit” can be attached to the proximal end of the overtube to maintain insufflation and minimize leakage of air during endoscopic treatment. The overtube can be locked with the mouthpiece to maintain the proper placement of the overtube.
Catalog Number
-
Brand Name
Flexible Overtube
Version/Model Number
MD-48719
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
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
cc9e2b9a-a53e-4d78-92a7-72be66e976f0
Public Version Date
May 30, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2019
Package DI Number
24545499070092
Quantity per Package
1
Contains DI Package
04545499070098
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 211 |