iTIND System

GUDID 07290015518109

iTIND System Box of 5

MEDI-TATE LTD

Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term Bare-metal urethral stent, short-term

• Primary Device ID: 07290015518109
• NIH Device Record Key: 3713a809-ea8b-4184-827f-2e16d211158d
• Commercial Distribution Discontinuation: 2020-11-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iTIND System
• Version Model Number: MT-FA05
• Company DUNS: 532003626
• Company Name: MEDI-TATE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015518109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190020

FDA Product Code

• QKA: Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-25
• Device Publish Date: 2020-11-10

On-Brand Devices [iTIND System]

• 07290015518109: iTIND System Box of 5
• 07290015518062: iTIND System