Cystoscopy obturator

GUDID 04059082010199

SOPRO-COMEG GmbH

Rigid endoscope obturator

• Primary Device ID: 04059082010199
• NIH Device Record Key: 0733bec5-42be-4a67-86e8-f7d10004fdf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscopy obturator
• Version Model Number: 196 070 400BC
• 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	04059082010199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945262

FDA Product Code

• FAJ: Cystoscope and accessories, flexible/rigid

Sterilization

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

[04059082010199]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-22

On-Brand Devices [Cystoscopy obturator]

• 04059082030685: 198 070 500
• 04059082030678: 198 070 400
• 04059082030661: 198 070 300
• 04059082030623: 198 040 500
• 04059082030616: 198 040 400
• 04059082030609: 198 040 300
• 04059082030593: 198 040 200
• 04059082030586: 198 040 100
• 04059082030463: 196 800 110
• 04059082030357: 196 070 400
• 04059082030340: 196 070 300
• 04059082030333: 196 070 200
• 04059082030326: 196 070 100
• 04059082030289: 196 040 500
• 04059082030272: 196 040 400
• 04059082030265: 196 040 301
• 04059082030258: 196 040 300
• 04059082030241: 196 040 200
• 04059082030234: 196 040 100
• 04059082025483: 395 015 030
• 04059082025476: 395 015 029
• 04059082025469: 395 015 028
• 04059082010625: 198 070 500BC
• 04059082010618: 198 070 400BC
• 04059082010601: 198 070 300BC
• 04059082010557: 198 040 500BC
• 04059082010540: 198 040 400BC
• 04059082010533: 198 040 300BC
• 04059082010526: 198 040 200BC
• 04059082010519: 198 040 100BC
• 04059082010335: 196 800 110BC
• 04059082010199: 196 070 400BC
• 04059082010182: 196 070 300BC
• 04059082010175: 196 070 200BC
• 04059082010168: 196 070 100BC
• 04059082010113: 196 040 500BC
• 04059082010106: 196 040 400BC
• 04059082010090: 196 040 301BC
• 04059082010083: 196 040 300BC
• 04059082010076: 196 040 200BC
• 04059082010069: 196 040 100BC