Tube set for irrigation, single use

GUDID 04056702004484

W.O.M. World of Medicine GmbH

Surgical irrigation tubing set, single-use

• Primary Device ID: 04056702004484
• NIH Device Record Key: 622ca7e5-b278-452c-b669-dba47ceeaa0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube set for irrigation, single use
• Version Model Number: A4054
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056702004477 [Primary]
GS1	04056702004484 [Package]; Contains: 04056702004477; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022449

FDA Product Code

• HIG: Insufflator, Hysteroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-12-19

On-Brand Devices [Tube set for irrigation, single use]

• 04056702004507: A4056
• 04056702004484: A4054
• 04056702003685: T0449-01