Duns Number:198227881
Device Description: Welch Allyn Green Series LED Portable Headlight; One White LED, 40 Lumens, 5,500° K; Soft Welch Allyn Green Series LED Portable Headlight; One White LED, 40 Lumens, 5,500° K; Soft Terrycloth Headband; 230 V, 50-60 Hz AC, Rechargeable (#72270) Battery; IEC Plug Type-G
Catalog Number
46074
Brand Name
Welch Allyn, Inc.
Version/Model Number
901069
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 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
-
Product Code
FSR
Product Code Name
Light, headband, surgical
Public Device Record Key
8cb3c2d5-aed0-4be9-a794-43be8b6d8d12
Public Version Date
May 31, 2021
Public Version Number
6
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 |