Duns Number:530269083
Device Description: The diameter of the spring tip is 1.8mm, the diameter of the wire guide rod is 0.8mm, and The diameter of the spring tip is 1.8mm, the diameter of the wire guide rod is 0.8mm, and the effective working length is 2100mm.
Catalog Number
-
Brand Name
MT
Version/Model Number
DG-18-08-21
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
4678ebcb-9d84-4109-b5a1-5f25d59ffead
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
16932503525111
Quantity per Package
10
Contains DI Package
06932503525114
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 |