Duns Number:071595540
Device Description: Marked Spring Tip Guidewire
Catalog Number
000150
Brand Name
N/A
Version/Model Number
000150
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
-
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
KNQ
Product Code Name
Dilator, esophageal
Public Device Record Key
59fa82a0-2040-4276-a7b4-dfefd5d35e51
Public Version Date
March 23, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405050855
Quantity per Package
2
Contains DI Package
10653405050858
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |