Duns Number:198227881
Device Description: Welch Allyn Green Series LED Procedure Headlight; One White LED, 120 Lumens, 5,500° K; Rig Welch Allyn Green Series LED Procedure Headlight; One White LED, 120 Lumens, 5,500° K; Rigid Headband; 230 V, 50-60 Hz AC, IEC Plug Type-E/F
Catalog Number
49022
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
260aa0b2-c3c5-4cd6-ad5c-b060d5909cee
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
September 21, 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 |