Duns Number:689908411
Device Description: This Head-worn light is used for medical examination by fixing it on the head and illumina This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and can be used for all medical field except ophthalmology.
Catalog Number
CTD-HL-001
Brand Name
N/A
Version/Model Number
BT-410A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HPP
Product Code Name
Headlamp, Operating, Battery-Operated
Public Device Record Key
7625992e-9468-4ad1-84d3-abc415288564
Public Version Date
February 07, 2019
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
00887529000366
Quantity per Package
1
Contains DI Package
00887529000342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Gift Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |