Duns Number:551540334
Device Description: Insert Earphone Tips
Catalog Number
-
Brand Name
Ear Tip IT-02 Pack/250 pcs.
Version/Model Number
100899-250
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 23, 2020
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
K133012,K133012
Product Code
ETT
Product Code Name
Cushion, Earphone (For Audiometric Testing)
Public Device Record Key
b6ea05c8-e4ce-47b3-a93e-bfcbdeabdad3
Public Version Date
June 24, 2020
Public Version Number
4
DI Record Publish Date
June 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 152 |