DEVICE: THD Revolution (08033737710739)
Device Identifier (DI) Information
THD Revolution
THD Slide One USA
In Commercial Distribution
800070
THD SPA
THD Slide One USA
In Commercial Distribution
800070
THD SPA
THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD Slide One box contains 10 individually packed disposable doppler probes, which can be immediately be used without preventive cleaning and sterilisation. The box also con-tains 10 absorbable sutures packs (6 sutures each pack) and 10 THD Spon-Anal haemostatic sponges
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61226 | Invasive vascular ultrasound system probe |
A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.
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Active | false |
44914 | Optical anoscope, single-use |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAF | Monitor, Ultrasonic, Nonfetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K090009 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c0badd07-fc58-402a-9ce7-3dd35ce31bd8
November 17, 2023
5
September 30, 2016
November 17, 2023
5
September 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
38033737710730 | 2 | 28033737710733 | In Commercial Distribution | ||
28033737710733 | 5 | 08033737710739 | In Commercial Distribution | ||
18033737710736 | 1 | 08033737710739 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+390522634311
Regulatory@thdlab.com
Regulatory@thdlab.com