MesireTM Sinus Balloon Catheter MSB50017

GUDID 18904224901466

MesireTM Sinus Balloon Catheter, 5.00 mm x 17 mm

MERIL LIFE SCIENCES PRIVATE LIMITED

Nasal/paranasal balloon catheter

• Primary Device ID: 18904224901466
• NIH Device Record Key: 3fcbceff-97bd-48cf-9a2e-e6fcfc152e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MesireTM Sinus Balloon Catheter
• Version Model Number: MSB50017
• Catalog Number: MSB50017
• Company DUNS: 650328680
• Company Name: MERIL LIFE SCIENCES PRIVATE LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (609) 951 2287
• Email: askmozec@merillife.com
• Phone: +1 (609) 951 2287
• Email: askmozec@merillife.com

Device Dimensions

• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 40°C; temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 40°C; temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	18904224901466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172737

FDA Product Code

• LRC: Instrument, Ent Manual Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-05-30

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