Duns Number:007198742
Device Description: Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle e Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear while creating an avenue passage for air pressure equalization on either side of the drum
Catalog Number
-
Brand Name
SHEEHY COLLAR BUTTON PACIFIC 127MM ID FLUOROPLASTIC
Version/Model Number
70143075
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
K000801,K000801
Product Code
ETD
Product Code Name
Tube, Tympanostomy
Public Device Record Key
ae34460d-5734-40c0-ad63-e29dc24ce562
Public Version Date
January 22, 2021
Public Version Number
4
DI Record Publish Date
October 24, 2015
Package DI Number
00821925020597
Quantity per Package
30
Contains DI Package
00821925039179
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |