Dilation set

GUDID 04059082015200

SOPRO-COMEG GmbH

Urethral bougie, reusable

• Primary Device ID: 04059082015200
• NIH Device Record Key: 963fa611-e939-4410-ab38-b4e3ab0cf024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dilation set
• Version Model Number: 392 999 111
• 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	04059082015200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082015200]

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: 2016-09-12

On-Brand Devices [Dilation set]

• 04059082033228: 191 402 257
• 04059082032320: 195 800 050
• 04059082015200: 392 999 111
• 04059082015163: 392 999 100
• 04059082009667: 195 800 050BC
• 04059082007632: 191 402 257BC