GeniClip Applier

GUDID 00877972004431

GENICON, INC.

Open-surgery ligation clip applier

• Primary Device ID: 00877972004431
• NIH Device Record Key: 4a5672fb-37a2-40e9-b398-3408f8542ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniClip Applier
• Version Model Number: 350-010-003
• Company DUNS: 079805400
• Company Name: GENICON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00877972004431 [Primary]

FDA Product Code

• HBT: Applier, Hemostatic Clip

Sterilization

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

[00877972004431]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2017-05-05

On-Brand Devices [GeniClip Applier]

• 00877972006374: 350-010-090
• 00877972004592: 350-005-000
• 00877972004431: 350-010-003
• 00877972004424: 350-010-002
• 00877972004417: 350-010-001
• 00877972004400: 350-010-000