Cap

GUDID 00877972000402

GENICON, INC.

Laparoscopic access cannula seal reducer

• Primary Device ID: 00877972000402
• NIH Device Record Key: 360bea3d-7556-4739-9d6f-d2e2a42f4603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cap
• Version Model Number: 100-005-631
• 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	00877972000402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982472

FDA Product Code

• GEA: Cannula, Surgical, General & Plastic Surgery

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 [Cap]

• 00877972000419: 100-010-744
• 00877972000402: 100-005-631