DEVICE: THD Revolution (08033737710739)

Device Identifier (DI) Information

THD Revolution
THD Slide One USA
In Commercial Distribution
800070
THD SPA
08033737710739
GS1

1
338430324 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
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.
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAF Monitor, Ultrasonic, Nonfetal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090009 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c0badd07-fc58-402a-9ce7-3dd35ce31bd8
November 17, 2023
5
September 30, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+390522634311
Regulatory@thdlab.com
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