Hysteroscope

GUDID 04059082003764

SOPRO-COMEG GmbH

Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope

• Primary Device ID: 04059082003764
• NIH Device Record Key: a03eb5fd-50df-47bf-90cd-08973dff49c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hysteroscope
• Version Model Number: 163 202 990BC001
• 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	04059082003764 [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

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

Moist Heat or Steam Sterilization

[04059082003764]

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