Duns Number:198227881
Device Description: Welch Allyn Binocular Indirect Ophthalmoscope with Padded Headband, Colbalt-Blue Filter, D Welch Allyn Binocular Indirect Ophthalmoscope with Padded Headband, Colbalt-Blue Filter, Diffuser Filter, Power Cord (8 ft/2.7 m), Small Carrying Case; Portable Power Source (#s 7436X); IEC Plug Type-G
Catalog Number
12234-D
Brand Name
Welch Allyn, Inc.
Version/Model Number
901023
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 19, 2021
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
K930023
Product Code
HLI
Product Code Name
Ophthalmoscope, ac-powered
Public Device Record Key
2d94283b-6f8f-413b-8441-d1e192c5dbe6
Public Version Date
November 22, 2021
Public Version Number
2
DI Record Publish Date
May 06, 2021
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 |