ARTHRO-Pump

GUDID 04056702008901

W.O.M. World of Medicine GmbH

Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system

• Primary Device ID: 04056702008901
• NIH Device Record Key: 6ef6df64-39f7-4cf6-b1e4-2019e2517923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTHRO-Pump
• Version Model Number: ZEOSINFLOW
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	04056702008901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173311

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-11-01

On-Brand Devices [ARTHRO-Pump]

• 04056702004699: PA304
• 04056702008901: ZEOSINFLOW