Duns Number:338430324
Device Description: The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with t The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with the THDSlide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindricalanodised aluminium attachment for connection to the light source of the generator (THD Evolution /THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusivelyfor THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to preventdamaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily andcomfortably use the instrument.
Catalog Number
880018
Brand Name
THD SLIDE ONE
Version/Model Number
THD OPTI-FIBER (EVO/BT)
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"
Yes
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
K090009
Product Code
JAF
Product Code Name
Monitor, Ultrasonic, Nonfetal
Public Device Record Key
19537d1e-d24e-41c5-8495-b373d89f057e
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |