Duns Number:017416582
Device Description: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's f A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source.
Catalog Number
-
Brand Name
Surgical Headlight
Version/Model Number
Premium Double Adjustable Headgear
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061690
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
8bbd6ae7-ecfb-48c9-a154-bb9a2ca6fdb1
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |