Duns Number:030849173
Device Description: SHEPARD GROMMET VENT TUBE 1.02MM ID - FLUOROPLASTIC PAIR 60 PACK
Catalog Number
-
Brand Name
SHEPARD GROMMET VENT TUBE
Version/Model Number
520-116
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K943325,K943325
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
585aeeaf-71e9-4114-b801-4644b19e0bea
Public Version Date
January 22, 2021
Public Version Number
6
DI Record Publish Date
February 18, 2016
Package DI Number
10844505008287
Quantity per Package
60
Contains DI Package
00844505008280
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 |