rezum

GUDID 00855357006010

Delivery Device Kit for BPH

NXTHERA, INC.

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 00855357006010
• NIH Device Record Key: 2745120f-5e03-4834-b90a-abf8520cf4fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rezum
• Version Model Number: D2201
• Company DUNS: 947824194
• Company Name: NXTHERA, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7635150061
• Email: ksimpson@nxthera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855357006010 [Primary]

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-19
• Device Publish Date: 2017-07-17

Devices Manufactured by NXTHERA, INC.

• 08714729986843 - rezum Generator: 2019-11-19
• 08714729986850 - rezum Generator: 2019-11-19
• 08714729986867 - rezum Generator: 2019-11-19
• 08714729986874 - rezum Generator: 2019-11-19
• 00855357006003 - rezum Generator: 2019-11-19
• 00855357006010 - rezum: 2019-11-19Delivery Device Kit for BPH
• 00855357006010 - rezum: 2019-11-19 Delivery Device Kit for BPH
• 00855357006041 - Rezūm Accessory Kit: 2018-11-22