Duns Number:198227881
Device Description: Welch Allyn 3.5 V Halogen HPX Coaxial Ophthalmoscope with Fixation Aperature, Power Handle Welch Allyn 3.5 V Halogen HPX Coaxial Ophthalmoscope with Fixation Aperature, Power Handle Not Included
Catalog Number
11721
Brand Name
Welch Allyn, Inc.
Version/Model Number
901081
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
HLJ
Product Code Name
Ophthalmoscope, battery-powered
Public Device Record Key
aba916f6-f11d-49c3-acc2-e3973c62b28d
Public Version Date
June 27, 2022
Public Version Number
3
DI Record Publish Date
September 17, 2016
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 |