Hysteroscope

GUDID 04059082003894

SOPRO-COMEG GmbH

Rigid optical hysteroscope

• Primary Device ID: 04059082003894
• NIH Device Record Key: a5fbf6bb-452c-4aea-85f5-c81adf926eb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hysteroscope
• Version Model Number: 163 412 982BC001
• 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: false
• 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	04059082003894 [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

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

[04059082003894]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-12-22

On-Brand Devices [Hysteroscope]

• 04059082032498: 163 412 992
• 04059082032481: 163 412 990
• 04059082032474: 163 412 982
• 04059082032467: 163 412 981
• 04059082032450: 163 412 980
• 04059082032443: 163 282 992
• 04059082032436: 163 282 990
• 04059082032429: 163 202 990
• 04059082032412: 163 202 600
• 04059082003924: 163 412 992BC001
• 04059082003917: 163 412 990BC001
• 04059082003894: 163 412 982BC001
• 04059082003870: 163 412 981BC001
• 04059082003856: 163 412 980BC001
• 04059082003818: 163 282 992BC001
• 04059082003795: 163 282 990BC001
• 04059082003764: 163 202 990BC001
• 04059082003757: 163 202 600BC001