Duns Number:198227881
Device Description: Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (# 11820), Elite Streak Retinoscope (#18240), Rechargeable 120-Minute Power Handle(s), Hard Storage Case, Fixation Cards, C-Cell Battery Converter Accessory; Lithium-Ion (#71960) Battery; IEC Plug Type-A
Catalog Number
18320-PSM
Brand Name
Welch Allyn, Inc.
Version/Model Number
901026
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2019
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
ERA
Product Code Name
OTOSCOPE
Public Device Record Key
ae881765-0637-450d-b1d2-b8fa716287aa
Public Version Date
May 10, 2021
Public Version Number
4
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 |