SimplyStrong

GUDID 00877972006053

GENICON, INC.

Tissue extraction bag

• Primary Device ID: 00877972006053
• NIH Device Record Key: c91a37e1-f486-4443-8b47-daebfddf808f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimplyStrong
• Version Model Number: 550-000-009
• 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	00877972006053 [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: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-05-05

On-Brand Devices [SimplyStrong]

• 00877972006138: 550-000-017
• 00877972006114: 550-000-013
• 00877972006091: 550-000-012
• 00877972006077: 550-000-011
• 00877972006053: 550-000-009
• 00877972005933: 550-000-010