Epistat

GUDID 00763000340353

CATHETER 1527031 EPISTAT NASAL

MEDTRONIC XOMED, INC.

Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon Nasal haemostatic balloon

• Primary Device ID: 00763000340353
• NIH Device Record Key: 0bf42d3d-6203-4944-9463-22ccdff9bc3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epistat
• Version Model Number: 1527031
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000340353 [Primary]

FDA Product Code

• EMX: BALLOON, EPISTAXIS

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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000849573 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE
• 00763000849580 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE-RF REFURBISHED
• 00763000882389 - NIM: 2024-02-12 EMG TUBE 8229306 NIM STD 6MM ROHS
• 00763000882396 - NIM: 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000882402 - NIM: 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000882419 - NIM: 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS
• 00763000882426 - NIM: 2024-02-12 EMG TUBE 8229507 NIM CONT 7MM ROHS
• 00763000882433 - NIM: 2024-02-12 EMG TUBE 8229508 NIM CONT 8MM ROHS