Duns Number:530269083
Device Description: The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Angle ti The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Angle tip,Normal shaft,Smooth surface
Catalog Number
-
Brand Name
MT
Version/Model Number
MTN-BM-89/45-A-J
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"
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
-
Product Code
OCY
Product Code Name
Endoscopic Guidewire, Gastroenterology-Urology
Public Device Record Key
37f3d853-ab85-4806-905b-e20d122131c5
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
16932503510117
Quantity per Package
2
Contains DI Package
06932503510110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |