Duns Number:627879687
Device Description: Initial Placement 20FR Guidewire PEG Kit
Catalog Number
00710802
Brand Name
NA
Version/Model Number
00710802
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 2019
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
2b8d98ed-9881-429f-996e-56b8f0bf4d37
Public Version Date
March 25, 2019
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
10816765010768
Quantity per Package
2
Contains DI Package
00816765010761
Package Discontinue Date
March 25, 2019
Package Status
Not 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |