Resectoscopy sheath

GUDID 04059082009797

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082009797
• NIH Device Record Key: e03d195a-875a-4bc3-b90a-d8e5a6b666fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resectoscopy sheath
• Version Model Number: 195 810 101BC
• 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	04059082009797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• FDC: RESECTOSCOPE, WORKING ELEMENT

Sterilization

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

[04059082009797]

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: 2016-09-12

On-Brand Devices [Resectoscopy sheath]

• 04059082031842: 199 530 500
• 04059082031811: 199 075 020
• 04059082031750: 199 040 540
• 04059082031743: 199 040 530
• 04059082031736: 199 040 516
• 04059082031729: 199 040 515
• 04059082031712: 199 040 514
• 04059082031705: 199 040 510
• 04059082031699: 199 040 010
• 04059082031682: 199 030 540
• 04059082031675: 199 030 514
• 04059082031668: 199 020 514
• 04059082031613: 195 810 101
• 04059082031583: 195 800 100
• 04059082031552: 195 400 010
• 04059082031514: 195 200 250
• 04059082031415: 195 040 540
• 04059082031408: 195 040 530
• 04059082031392: 195 040 525
• 04059082031385: 195 040 523
• 04059082031378: 195 040 518
• 04059082031361: 195 040 514
• 04059082031354: 195 040 025
• 04059082031347: 195 040 010
• 04059082031330: 195 030 521
• 04059082031323: 195 030 514
• 04059082031316: 195 030 501
• 04059082031309: 195 020 514
• 04059082025452: 395 015 027
• 04059082025445: 395 015 025
• 04059082025438: 395 015 020
• 04059082011028: 199 530 500BC
• 04059082010878: 199 075 020BC
• 04059082010809: 199 040 540BC
• 04059082010793: 199 040 530BC
• 04059082010779: 199 040 516BC
• 04059082010762: 199 040 515BC
• 04059082010755: 199 040 514BC
• 04059082010748: 199 040 510BC
• 04059082010731: 199 040 010BC
• 04059082010717: 199 030 540BC
• 04059082010700: 199 030 514BC
• 04059082010694: 199 020 514BC
• 04059082009797: 195 810 101BC
• 04059082009704: 195 800 100BC
• 04059082009520: 195 400 010BC
• 04059082009476: 195 200 250BC
• 04059082008783: 195 040 540BC
• 04059082008776: 195 040 530BC
• 04059082008752: 195 040 525BC