rezum Generator

GUDID 08714729986867

NXTHERA, INC.

Electrosurgical system generator

• Primary Device ID: 08714729986867
• NIH Device Record Key: f91f06b5-35b4-45cb-a7b0-82c09ee84123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rezum Generator
• Version Model Number: G2200-003H
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729986867 [Primary]

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-19
• Device Publish Date: 2018-12-15

On-Brand Devices [rezum Generator]

• 00855357006003: G2200
• 08714729986874: G2200-003Z
• 08714729986867: G2200-003H
• 08714729986850: G2200-003D
• 08714729986843: G2200-003R