THD N-ano anoscope 800134

GUDID 28033737710702

The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal. The THD N-ano anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The THD N-ano anoscope is ready-to-use and does not need for other tools.

THD SPA

Optical anoscope, single-use

• Primary Device ID: 28033737710702
• NIH Device Record Key: 4c4f8322-020d-48a0-9cb0-0fc87efaaa0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD N-ano anoscope
• Version Model Number: THD Anoscope N-ano Bevelled
• Catalog Number: 800134
• 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
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com

Device Dimensions

• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 21.7 Millimeter
• Length: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033737710708 [Primary]
GS1	18033737710705 [Package]; Contains: 08033737710708; Package: [10 Units]; In Commercial Distribution
GS1	28033737710702 [Package]; Contains: 08033737710708; Package: [50 Units]; In Commercial Distribution
GS1	38033737710709 [Package]; Contains: 08033737710708; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133687

FDA Product Code

• FER: Anoscope And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2016-10-07

On-Brand Devices [THD N-ano anoscope]

• 38033737710723: The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal
• 28033737710719: The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal
• 28033737710702: The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal
• 18033737710699: The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal
• 18051887044778: THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into
• 18051887044754: THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into
• 18051887044730: THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into