GeniStrong

GUDID 00877972007081

GENICON, INC.

Tissue extraction bag

• Primary Device ID: 00877972007081
• NIH Device Record Key: d035c945-a500-40c0-9034-9e0671ab36dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniStrong
• Version Model Number: 550-000-009G
• 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	00877972007081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132375

FDA Product Code

• GCJ: Laparoscope, 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: 2018-01-15

On-Brand Devices [GeniStrong]

• 00877972007180: 550-000-017G
• 00877972007166: 550-000-013G
• 00877972007142: 550-000-012G
• 00877972007128: 550-000-011G
• 00877972007104: 550-000-010G
• 00877972007081: 550-000-009G
• 00877972007067: 550-000-008G
• 00877972007043: 550-000-005G
• 00877972007029: 550-000-003G
• 00877972005919: 550-000-008
• 00877972005186: 550-000-005
• 00877972004004: 550-000-003