GeniClip

GUDID 00877972004530

GENICON, INC.

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• Primary Device ID: 00877972004530
• NIH Device Record Key: 0527db1e-9010-4297-9173-da6cb4627120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniClip
• Version Model Number: 350-000-102
• Company DUNS: 079805400
• Company Name: GENICON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00877972004530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100090

FDA Product Code

• FZP: Clip, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-05

On-Brand Devices [GeniClip]

• 00877972004578: 350-000-104
• 00877972004554: 350-000-103
• 00877972004530: 350-000-102
• 00877972004516: 350-000-101