HysteroLux™ Hysteroscopic Inflow Tube Set

GUDID 04056702005795

W.O.M. World of Medicine GmbH

Surgical irrigation tubing set, single-use

• Primary Device ID: 04056702005795
• NIH Device Record Key: e5c94a84-7ca7-4657-910d-531e1665a47d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HysteroLux™ Hysteroscopic Inflow Tube Set
• Version Model Number: 72205028
• Company DUNS: 316305242
• Company Name: W.O.M. World of Medicine GmbH
• 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: true
• 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	04056702005795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173489

FDA Product Code

• HET: Laparoscope, Gynecologic (And 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: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-04-18

Devices Manufactured by W.O.M. World of Medicine GmbH

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• 04056702012878 - Fluid Monitoring Unit: 2024-07-08
• 04056702008789 - Heating tube set for insufflation, single use: 2020-11-09
• 04056702008802 - Tube set for insufflation, single-use: 2020-11-09
• 04056702008826 - Tube set for suction, single-use: 2020-11-09
• 04056702008840 - Tube set for suction (with 2 ports), single-use: 2020-11-09
• 04056702008864 - Tube set for irrigation, single-use: 2020-11-09
• 04056702008888 - Tube set for vacuum incl. filter, 30-day use: 2020-11-09