Duns Number:835465063
Device Description: VENT TUBE 1019101 5PK SHANK .89/7MM FLPL
Catalog Number
-
Brand Name
NA
Version/Model Number
1019101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
b447118c-2652-41cf-a81b-d626a156ee81
Public Version Date
January 22, 2021
Public Version Number
4
DI Record Publish Date
July 07, 2015
Package DI Number
20613994176633
Quantity per Package
5
Contains DI Package
00613994176639
Package Discontinue Date
October 24, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |