Duns Number:656738726
Device Description: Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway gen Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general purposed ultrasound probe for automatic multiple-angle ultrasound scan.
Catalog Number
-
Brand Name
Head & Neck Laser Alignment Tool
Version/Model Number
1.0
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
IWE
Product Code Name
Monitor, Patient Position, Light-Beam
Public Device Record Key
31687248-e5b2-465f-a010-4734cdb0ea45
Public Version Date
August 08, 2019
Public Version Number
1
DI Record Publish Date
July 31, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |