GeniFirst

GUDID 00877972001904

GENICON, INC.

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 00877972001904
• NIH Device Record Key: 88c371f8-1db8-473f-941f-0eebfee9ea00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniFirst
• Version Model Number: 130-150-001
• 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: 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	00877972001904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993625

FDA Product Code

• HIF: Insufflator, Laparoscopic

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 [GeniFirst]

• 00877972001904: 130-150-001
• 00877972001898: 130-120-001