Urology syringe

GUDID 04059082032016

SOPRO-COMEG GmbH

General-purpose syringe, reusable

• Primary Device ID: 04059082032016
• NIH Device Record Key: a3bb233a-4721-42f1-8a53-544b6fcc8404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urology syringe
• Version Model Number: 195 090 100
• 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	04059082032016 [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

[04059082032016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-12
• Device Publish Date: 2018-03-20

On-Brand Devices [Urology syringe]

• 04059082032061: 199 090 200
• 04059082032054: 199 090 100
• 04059082032030: 195 091 000
• 04059082032023: 195 090 200
• 04059082032016: 195 090 100
• 04059082025513: 395 015 033
• 04059082025506: 395 015 032
• 04059082010915: 199 090 200 C
• 04059082010908: 199 090 100 C
• 04059082009032: 195 091 000BC
• 04059082008974: 195 090 302
• 04059082008967: 195 090 301
• 04059082008950: 195 090 300
• 04059082008943: 195 090 200 C
• 04059082008929: 195 090 100 C