Nephroscopy sheath

GUDID 04059082009643

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082009643
• NIH Device Record Key: 4849e6f5-4584-48ce-980c-b3d173081f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephroscopy sheath
• Version Model Number: 195 800 035BC
• 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	04059082009643 [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

[04059082009643]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-12-22

On-Brand Devices [Nephroscopy sheath]

• 04059082030128: 195 800 035
• 04059082030111: 195 800 030
• 04059082030098: 195 800 010
• 04059082009643: 195 800 035BC
• 04059082009636: 195 800 030BC
• 04059082009605: 195 800 010BC