Duns Number:198227881
Device Description: Welch Allyn 3.5 V Halogen HPX Diagnostic Set including PanOptic Ophthalmoscope (#11810), M Welch Allyn 3.5 V Halogen HPX Diagnostic Set including PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), Rechargeable 1 20-Minute Power Handle(s), Universal Desk Charger; 100-240 V, 50-60 Hz AC, 2 Lithium-Ion (#71960) Batteries; IEC Plug Type-B
Catalog Number
71811-MPS
Brand Name
Welch Allyn, Inc.
Version/Model Number
901088
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
HLS
Product Code Name
EXOPHTHALMOMETER
Public Device Record Key
393d442d-fe46-4014-9c28-729b59fb6ec8
Public Version Date
June 27, 2022
Public Version Number
6
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 |