Accessory for urology

GUDID 04059082030821

SOPRO-COMEG GmbH

Urethral bougie, reusable

• Primary Device ID: 04059082030821
• NIH Device Record Key: eeb33012-7b46-475e-a15d-80ad483f2894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory for urology
• Version Model Number: 395 410 011
• 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	04059082030821 [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

[04059082030821]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

On-Brand Devices [Accessory for urology]

• 04059082030890: 395 410 018
• 04059082030883: 395 410 017
• 04059082030876: 395 410 016
• 04059082030869: 395 410 015
• 04059082030852: 395 410 014
• 04059082030845: 395 410 013
• 04059082030838: 395 410 012
• 04059082030821: 395 410 011
• 04059082030814: 395 410 010
• 04059082030807: 395 410 009
• 04059082030791: 395 410 008
• 04059082030784: 395 410 007
• 04059082030777: 395 410 005
• 04059082030760: 395 410 004
• 04059082030753: 395 410 003
• 04059082030746: 395 410 002
• 04059082030739: 395 410 001
• 04059082026602: 395 410 018BC
• 04059082026596: 395 410 017BC
• 04059082026589: 395 410 016BC
• 04059082026572: 395 410 015BC
• 04059082026565: 395 410 014BC
• 04059082026558: 395 410 013BC
• 04059082026541: 395 410 012BC
• 04059082026534: 395 410 011BC
• 04059082026527: 395 410 010BC
• 04059082026510: 395 410 009BC
• 04059082026503: 395 410 008BC
• 04059082026497: 395 410 007BC
• 04059082026473: 395 410 005BC
• 04059082026466: 395 410 004BC
• 04059082026459: 395 410 003BC
• 04059082026442: 395 410 002BC
• 04059082026435: 395 410 001BC