Duns Number:079375431
Device Description: MIC-KEY* Over-the-Wire Stoma Measuring Device
Catalog Number
98460
Brand Name
AVANOS
Version/Model Number
98460
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"
-
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
KGC
Product Code Name
TUBE, GASTRO-ENTEROSTOMY
Public Device Record Key
33452b66-48ca-4b2b-a9aa-f1ab08e150ad
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
September 08, 2019
Package DI Number
10350770984602
Quantity per Package
10
Contains DI Package
00350770984605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |