rezum M006D2201-003

GUDID 08714729992547

Delivery Device Kit for BPH

BOSTON SCIENTIFIC CORPORATION

Radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use

• Primary Device ID: 08714729992547
• NIH Device Record Key: b9e1cef9-3933-40b7-b66c-e2716ac26fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rezum
• Version Model Number: M006D2201-003
• Catalog Number: M006D2201-003
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729992547 [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: 2
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-08-09

On-Brand Devices [rezum]

• 08714729992547: Delivery Device Kit for BPH
• 00191506006785: Delivery Device