THD SLIDE ONE

Primary DI
08033737710869
Brand
THD SLIDE ONE
Company
THD SPA
Model
THD SLIDE
Catalog number
710004
Device description
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.
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAFMonitor, Ultrasonic, Nonfetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090009000THD SLIDE ONEThd Spa2009-01-28JAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033737710866PackageGS11In Commercial Distribution
08033737710869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803373771086618033737710866
08033737710869080337377108698033737710869

GMDN Terms#

Term, Definition table
TermDefinition
Optical proctoscope, single-useAn 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.

Contacts#

Phone, Email table
PhoneEmail
+390522634311Regulatory@thdlab.com

Regulatory Flags#

DUNS number
338430324
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033737710777THD SLIDE ONETHD OPTI-FIBER (REVO/BT)8800122022-09-01
18033737710781THD SLIDE ONETHD OPTI-FIBER (EVO/BT)8800182022-09-09
08051887049837THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
08051887049851THD BIOPSYTHD BIOPSY (J)8003172026-01-07
08051887049875THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
18051887049841THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
18051887049865THD BIOPSYTHD BIOPSY (J)8003172026-01-07
18051887049889THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
18033737710354THD SLIDE ONETHD DOPPLER PROBE (1s/ST)8000632025-10-30
08051887047918THD SLIDE ONETHD ANOLIFT US8003302025-04-03
18051887047915THD SLIDE ONETHD ANOLIFT US8003302025-04-03
08051887044719THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
08051887044733THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
08051887044757THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
08051887044771THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14
18051887044716THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
18051887044730THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
18051887044754THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
18051887044778THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14
08051887043286THD DIGITAL MINICAMTHD DIGITAL MINICAM8003052025-02-20

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