THD SLIDE ONE - The THD 880012 sterilizable flexible fibre optic - THD SPA

Duns Number:338430324

Device Description: The THD 880012 sterilizable flexible fibre optic cable is to be used in conjunction with t The THD 880012 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.

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More Product Details

Catalog Number

880012

Brand Name

THD SLIDE ONE

Version/Model Number

THD OPTI-FIBER (REVO/BT)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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,K090009

Product Code Details

Product Code

JAF

Product Code Name

Monitor, Ultrasonic, Nonfetal

Device Record Status

Public Device Record Key

3be1aec2-ecb4-4f76-abad-d4efb7f7ec86

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

18033737710774

Quantity per Package

1

Contains DI Package

08033737710777

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON BOX

"THD SPA" Characteristics
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