Ureterorenoscope

GUDID 04059082031903

SOPRO-COMEG GmbH

Rigid ureterorenoscope

• Primary Device ID: 04059082031903
• NIH Device Record Key: 8c3f62be-b7a1-4e21-8ab5-5ed8d6b2ed68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ureterorenoscope
• Version Model Number: 186 070 001
• 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	04059082031903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• FJL: RESECTOSCOPE

Sterilization

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

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

Moist Heat or Steam Sterilization

[04059082031903]

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: 2018-03-20

On-Brand Devices [Ureterorenoscope]

• 04059082032009: 186 558 001
• 04059082031996: 186 553 001
• 04059082031989: 186 552 001
• 04059082031972: 186 528 001
• 04059082031965: 186 514 001
• 04059082031958: 186 407 001
• 04059082031941: 186 406 001
• 04059082031934: 186 405 001
• 04059082031927: 186 403 001
• 04059082031910: 186 395 001
• 04059082031903: 186 070 001
• 04059082031897: 186 069 001
• 04059082031880: 185 900 100
• 04059082031873: 185 900 000
• 04059082004495: 186 558 001BC001
• 04059082004471: 186 553 001BC001
• 04059082004464: 186 552 001BC001
• 04059082004457: 186 528 001BC001
• 04059082004440: 186 514 001BC001
• 04059082004433: 186 407 001BC001
• 04059082004426: 186 406 001BC001
• 04059082004419: 186 405 001BC001
• 04059082004396: 186 403 001BC001
• 04059082004389: 186 395 001BC001
• 04059082004372: 186 070 001BC001
• 04059082004365: 186 069 001BC001
• 04059082004334: 185 900 100BC001
• 04059082004327: 185 900 000BC001