AccessGUDID - DEVICE: THD SLIDE ONE (18033737710781)

GUDID

Device Identifier (DI) Information

Brand Name: THD SLIDE ONE
Version or Model: THD OPTI-FIBER (EVO/BT)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 880018
Company Name: THD SPA

Primary DI Number: 18033737710781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised 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 exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAF	Monitor, Ultrasonic, Nonfetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090009	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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