Duns Number:001188390
Device Description: KIT CONTAINS 2 DLG-2 GREEN CROSS LASERS, 1 DLG-4 GREEN SAGITTAL LASER
Catalog Number
-
Brand Name
Huestis Centralite Patient Positioning Laser
Version/Model Number
CTL-DLG-2214
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)
-
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
d8104fec-f98c-4438-8d4b-0925ab21cdfa
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |