GeniPalm

GUDID 00877972004837

GENICON, INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 00877972004837
• NIH Device Record Key: 0b63ab23-62b3-490d-a7d8-6ec9cf7ba25d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniPalm
• Version Model Number: 100-005-151
• 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	00877972004837 [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: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-05-05

On-Brand Devices [GeniPalm]

• 00877972005254: 100-005-150
• 00877972005131: 100-112-151
• 00877972005117: 100-105-052
• 00877972005094: 100-105-051
• 00877972005070: 100-010-150
• 00877972005056: 100-005-052
• 00877972005032: 100-005-051
• 00877972005018: 100-005-050
• 00877972004998: 100-012-151
• 00877972004974: 100-012-150
• 00877972004936: 100-105-152
• 00877972004912: 100-005-152
• 00877972004899: 100-110-151
• 00877972004875: 100-105-151
• 00877972004851: 100-010-151
• 00877972004837: 100-005-151
• 00877972004462: 100-108-151