Ureterorenoscope

GUDID 04059082031989

SOPRO-COMEG GmbH

Rigid ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope Rigid optical ureterorenoscope

• Primary Device ID: 04059082031989
• NIH Device Record Key: 0a966f74-3a02-48e9-a47f-0b65ffd9a6c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ureterorenoscope
• Version Model Number: 186 552 001
• 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	04059082031989 [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

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

Moist Heat or Steam Sterilization

[04059082031989]

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