Duns Number:030849173
Device Description: MODIFIED ARMSTRONG GROMMET 1.14MM ID WHITE FLUOROPLASTIC PAIR 60 PACK
Catalog Number
-
Brand Name
MODIFIED ARMSTRONG GROMMET
Version/Model Number
520-276
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
K830228,K830228
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
b2a7aaf4-3427-469c-ba38-d363b10846fb
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
September 25, 2019
Package DI Number
10844505011935
Quantity per Package
60
Contains DI Package
00844505011938
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 200 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 564 |