Veress insufflation needle

GUDID 04059082013121

SOPRO-COMEG GmbH

Rigid endoscopic cannula, reusable

• Primary Device ID: 04059082013121
• NIH Device Record Key: 30f60b8e-6142-4201-b44d-c784f8db2ff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veress insufflation needle
• Version Model Number: 391 020 120
• 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	04059082013121 [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

[04059082013121]

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 [Veress insufflation needle]

• 04059082032351: 391 020 120
• 04059082032344: 391 020 100
• 04059082032337: 391 020 060
• 04059082013282: 391 127 150
• 04059082013275: 391 127 120
• 04059082013268: 391 127 100
• 04059082013251: 391 120 150
• 04059082013244: 391 120 120
• 04059082013237: 391 120 100
• 04059082013183: 391 027 170
• 04059082013176: 391 027 150
• 04059082013169: 391 027 120
• 04059082013152: 391 027 100
• 04059082013138: 391 020 140
• 04059082013121: 391 020 120
• 04059082013114: 391 020 100
• 04059082013107: 391 020 060