Duns Number:486911852
Device Description: Gastric Calibration Tube
Catalog Number
RGCT360
Brand Name
N/A
Version/Model Number
RGCT360
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 13, 2020
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
5ab83e01-efd2-4368-bdde-dcb8380ad072
Public Version Date
April 14, 2020
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036003988
Quantity per Package
42
Contains DI Package
20705036003981
Package Discontinue Date
April 13, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 2 |