Symphion

GUDID 08714729863717

Tissue Removal System Fluid Management Accessories

BOSTON SCIENTIFIC CORPORATION

Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system

• Primary Device ID: 08714729863717
• NIH Device Record Key: d2c40991-2221-4ab1-9f9b-c505d42069ef
• Commercial Distribution Discontinuation: 2021-01-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Symphion
• Version Model Number: FG-0202
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729863717 [Primary]

FDA Product Code

• PGT: Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-07-20
• Device Publish Date: 2016-09-24

On-Brand Devices [Symphion]

• 08714729905806: Tissue Removal System Refurbished 6.3 Endoscope
• 08714729863670: Tissue Removal System 6.3 Endoscope
• 08714729897279: Tissue Removal System Refurbished Controller
• 08714729893318: Tissue Removal System Spare Footswitch
• 08714729863717: Tissue Removal System Fluid Management Accessories
• 08714729863687: Tissue Removal System Controller
• 08714729863656: Tissue Removal System Resecting Device