HysteroLux™ Hysteroscopic Vacuum Tube Set

GUDID 04056702005825

W.O.M. World of Medicine GmbH

Vacuum tubing, single-use Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing Disposable vacuum tubing

• Primary Device ID: 04056702005825
• NIH Device Record Key: 631f2d2f-60af-45d5-9345-2df6e0d9b589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HysteroLux™ Hysteroscopic Vacuum Tube Set
• Version Model Number: 72205027
• 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: false
• 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	04056702005825 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

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

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• 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
• 04056702008895 - Insufflator 50L: 2020-11-09
• 04056702008901 - ARTHRO-Pump: 2020-11-09