Duns Number:198227881
Device Description: Welch Allyn SureColor LED 2.5 V Pocket Plus Ophthalmoscope; AA-Battery Handle, Soft Storag Welch Allyn SureColor LED 2.5 V Pocket Plus Ophthalmoscope; AA-Battery Handle, Soft Storage Case, Matching Handle Bumpers; Onyx; 2 Alkaline AA Batteries
Catalog Number
12880-BLK
Brand Name
Welch Allyn, Inc.
Version/Model Number
901082
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
ERA
Product Code Name
OTOSCOPE
Public Device Record Key
84b0134f-79e5-4000-9cef-8944450e10d8
Public Version Date
March 29, 2018
Public Version Number
2
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 |