Accessory for gynecology

GUDID 04059082032689

SOPRO-COMEG GmbH

Uterine sound, reusable

• Primary Device ID: 04059082032689
• NIH Device Record Key: c82c60d4-54eb-45dd-8e64-313e3c85f7ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory for gynecology
• Version Model Number: 391 061 700
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG 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: 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	04059082032689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945265

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[04059082032689]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

On-Brand Devices [Accessory for gynecology]

• 04059082032689: 391 061 700
• 04059082013190: 391 061 700