Duns Number:332288104
Device Description: Touch OrthoPhys -Trolley version (12000).This device is Laserneedle Touch Orthophys with 5 Touch OrthoPhys -Trolley version (12000).This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers.Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts:- Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244)- Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275)- Trolley with power supply (Touch OrthoPhys -Trolley version (12000).This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers.Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts:- Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244)- Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275)- Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213)- Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305)- LN Tape (Product number: 40100 Primary DI number: 4260649160466)- Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404)- LN Tip caps (Product number: 40710 Primary DI number: 4260649160503)- Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312)- Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)
Catalog Number
-
Brand Name
Laserneedle Touch
Version/Model Number
12000-Trolley
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"
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For Single-Use
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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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
48ede6ee-1ce7-4c43-a94f-d81903a47b01
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
March 14, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |