A Li Gator

GUDID 00877972006343

GENICON, INC.

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• Primary Device ID: 00877972006343
• NIH Device Record Key: 4680c5c0-dbdb-4e5b-8661-51d98d2f4b81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A Li Gator
• Version Model Number: 360-010-001
• 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	00877972006343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030269

FDA Product Code

• GDO: Applier, Surgical, Clip

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

Devices Manufactured by GENICON, INC.

• 00877972000334 - Kit: 2020-01-09
• 00877972000426 - GeniShield: 2020-01-09
• 00877972000433 - GeniShield: 2020-01-09
• 00877972000440 - GeniShield: 2020-01-09
• 00877972000464 - GeniShield: 2020-01-09
• 00877972000471 - GeniShield: 2020-01-09
• 00877972000488 - GeniShield: 2020-01-09
• 00877972000495 - GeniPort: 2020-01-09