Duns Number:198227881
Device Description: Welch Allyn SofSeal Disposable Ear Specula; Qty. 80
Catalog Number
24320-B
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
ETY
Product Code Name
Tester, auditory impedance
Public Device Record Key
14c65f3f-dec3-4d4f-8445-b3b9fc182e3a
Public Version Date
June 23, 2022
Public Version Number
3
DI Record Publish Date
June 22, 2020
Package DI Number
00732094083798
Quantity per Package
6
Contains DI Package
00732094011968
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 |