Duns Number:835465063
Device Description: VENT TUBE 1028081 5PK HOFFMAN PERM LINER
Catalog Number
-
Brand Name
NA
Version/Model Number
1028081
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
924c13d3-0c17-4772-aa36-333b7b0662cd
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 17, 2015
Package DI Number
20681490030063
Quantity per Package
5
Contains DI Package
00681490030069
Package Discontinue Date
-
Package Status
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 |