DEVICE: THD SLIDE ONE (08033737710869)

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If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

THD SLIDE ONE
THD SLIDE
In Commercial Distribution
710004
THD SPA
08033737710869
GS1

1
338430324 *Terms of Use
The THD Slide proctoscope includes a handle and an anatomically shaped sliding part to be inserted transanally in the rectum during the surgical procedure. The handle is shaped so that the tip of the THD Fiber Optic Cable can be inserted. A slot on the sliding part accommodates the Doppler transducer (THD Doppler Probe). The upper portion of the proctoscope includes a window to access the surgical area: this characteristic permits the physician to slide this part during the operation and to position the window correctly for the artery ligation. The movement of the upper part of THD Slide proctoscope allows the physician to obtain a wide surgical window that can be moved in the rectum to facilitate the ligation of the artery and to perform a pexy to reduce the prolapse. The THD Slide device pack includes also a know tightner that facilitate the closure of the knot carried out with the surgical suture. This instrument allows the surgeon to push the knot towards the anal mucosa, avoiding that the surgeon should use his finger to perform this operation. The knot-tightener features a tiny groove for tightening the knot. THD Slide is individually packed and EO sterilized.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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?
40502 Optical proctoscope, single-use
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. 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
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

52972b13-3c7e-428a-9ea1-50833c7f2c84
November 07, 2025
1
October 30, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
18033737710866 1 08033737710869 In Commercial Distribution Carton box
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Secondary DI

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

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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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