Snare X5

GUDID 17290015518083

Pack of 5 individually packed Snare

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

• Primary Device ID: 17290015518083
• NIH Device Record Key: 66846eb7-3168-412b-b967-fb1046e8d23d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Snare X5
• Version Model Number: MT-FA09
• Company DUNS: 532003626
• Company Name: MEDI-TATE LTD
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290015518083 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-28
• Device Publish Date: 2021-07-20

Devices Manufactured by MEDI-TATE LTD

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• 07290015518079 - iTIND: 2023-07-25
• 07290015518086 - SNARE: 2023-07-25
• 07290015518109 - iTIND System: 2023-07-25 iTIND System Box of 5
• 17290015518083 - Snare X5: 2021-07-28Pack of 5 individually packed Snare
• 17290015518083 - Snare X5: 2021-07-28 Pack of 5 individually packed Snare