THD N-Ano anoscopes 800313

GUDID 18051887044716

THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integrates in the handle the seat for a dedicated slide for association of anoscope with THD DIGITAL MINICAM which allowing HD resolution shooting of the anoscopy examination. THD N-ANO DIGITAL anoscope is supplied with a convenient introducer, a camera slide and a camera protection bag.

THD SPA

Optical anoscope, single-use

• Primary Device ID: 18051887044716
• NIH Device Record Key: cf8cdc92-b3b3-4b84-aebf-a8cb5311516c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD N-Ano anoscopes
• Version Model Number: THD N-ANO DIGITAL (TR)
• Catalog Number: 800313
• Company DUNS: 338430324
• Company Name: THD SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com

Device Dimensions

• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 91 Millimeter
• Outer Diameter: 21.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051887044719 [Primary]
GS1	18051887044716 [Package]; Contains: 08051887044719; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133687

FDA Product Code

• GCP: Endoscope, Ac-Powered And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-24
• Device Publish Date: 2025-03-14

Devices Manufactured by THD SPA

• 18051887044716 - THD N-Ano anoscopes: 2025-03-24THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integrates in the handle the seat for a dedicated slide for association of anoscope with THD DIGITAL MINICAM which allowing HD resolution shooting of the anoscopy examination. THD N-ANO DIGITAL anoscope is supplied with a convenient introducer, a camera slide and a camera protection bag.
• 18051887044716 - THD N-Ano anoscopes: 2025-03-24 THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integr
• 18051887044730 - THD N-Ano anoscope: 2025-03-24 THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integr
• 18051887044754 - THD N-Ano Anoscope: 2025-03-24 THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integr
• 18051887044778 - THD N-ano anoscope: 2025-03-24 THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integr
• 18051887043283 - THD DIGITAL MINICAM: 2025-02-28 The THD DIGITAL MINICAM is a high-resolution video camera, which allows shooting in HD resolution using THD's N-Ano Digital diag
• 18051887043566 - THD BIOPSY: 2025-02-28 THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical
• 18051887045751 - THD BIOPSY: 2025-02-28 THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical
• 18051887047410 - THD BIOPSY: 2025-02-28 THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical