Probe

GUDID 00877972004370

GENICON, INC.

Surgical irrigation/aspiration cannula, non-illuminating, reusable

• Primary Device ID: 00877972004370
• NIH Device Record Key: 6459b871-41a3-449d-8348-ca3896c2e982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe
• Version Model Number: 707-005-045
• Company DUNS: 079805400
• Company Name: GENICON, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972004370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041967

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00877972004370]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-05-05

On-Brand Devices [Probe]

• 00877972007333: 700-010-033
• 00877972007319: 700-005-045
• 00877972004677: 700-005-033
• 00877972004370: 707-005-045
• 00877972002772: 707-010-033
• 00877972002765: 707-005-333
• 00877972002758: 707-005-233
• 00877972002741: 707-005-133
• 00877972002734: 707-005-033