Duns Number:198227881
Device Description: Single Use Ear Tips for OAE Hearing Screener and MicroTymp 4 Portable Tympanometer; 10 mm; Single Use Ear Tips for OAE Hearing Screener and MicroTymp 4 Portable Tympanometer; 10 mm; Qty. 25
Catalog Number
39422-10-025
Brand Name
Welch Allyn, Inc.
Version/Model Number
901001
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
-
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
PTP
Product Code Name
Tympanometer, exempt
Public Device Record Key
586495ae-c8b3-4fec-acae-b9f071fcc6ae
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |