Duns Number:124367223
Device Description: Surgical Headlight..1 - Headgear light weight single back adjustment..1 - Black headlight Surgical Headlight..1 - Headgear light weight single back adjustment..1 - Black headlight module, 90° 10-100mm variable spot..2 - Joysticks, detachable..1 - Set of cushioned detachable Blue foam sweatbands..1 - Mono-cable, 9ft with Wolf lens proximal
Catalog Number
SD3120H
Brand Name
Surgical Direct
Version/Model Number
SD3120H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K061690
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
483351e3-9f92-495d-9c8b-bd24f4932ae3
Public Version Date
May 06, 2020
Public Version Number
1
DI Record Publish Date
April 28, 2020
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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1010 |