Duns Number:198227881
Device Description: ADULT TIPS WITH SLEEVE
Catalog Number
419793
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
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
ERA
Product Code Name
OTOSCOPE
Public Device Record Key
d18d1e05-4f41-4a59-85e6-7c8bf0f5ec99
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
August 25, 2020
Package DI Number
00732094326406
Quantity per Package
10
Contains DI Package
00732094326413
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 | 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 |