Duns Number:198227881
Device Description: Welch Allyn Green Series LED Procedure Headlight; One White LED, 50 Lumens, 5,500° K; Rigi Welch Allyn Green Series LED Procedure Headlight; One White LED, 50 Lumens, 5,500° K; Rigid Headband; Power Source Not Included
Catalog Number
49000
Brand Name
Welch Allyn, Inc.
Version/Model Number
901069
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
FSR
Product Code Name
Light, headband, surgical
Public Device Record Key
348c4cd5-bf67-4e58-a07d-515724556dbe
Public Version Date
October 19, 2020
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 |