Hysteroscopy obturator

GUDID 04059082032627

SOPRO-COMEG GmbH

Rigid endoscope obturator

• Primary Device ID: 04059082032627
• NIH Device Record Key: c82dd09b-f4cf-4400-aa90-c7d869918ede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hysteroscopy obturator
• Version Model Number: 191 403 046
• 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	04059082032627 [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

[04059082032627]

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 [Hysteroscopy obturator]

• 04059082032627: 191 403 046
• 04059082032603: 191 293 046
• 04059082032542: 191 273 046
• 04059082032511: 191 203 046
• 04059082007670: 191 403 046BC
• 04059082006529: 191 293 046BC
• 04059082006420: 191 273 046BC
• 04059082006062: 191 203 046BC