SingleCycle Biohazard Self-Sealing label 15"

GUDID 30843356102391

SingleCycle Biohazard Self-Sealing label 15" 500 per case

CYGNUS MEDICAL L.L.C.

Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use Device operating status label/tag, single-use

• Primary Device ID: 30843356102391
• NIH Device Record Key: 52fc79cc-0861-4e8a-bb41-bff87385d3b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SingleCycle Biohazard Self-Sealing label 15"
• Version Model Number: SCB15
• Company DUNS: 103169095
• Company Name: CYGNUS MEDICAL L.L.C.
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843356102390 [Primary]
GS1	30843356102391 [Unit of Use]

FDA Product Code

• PXV: General Purpose Instrument Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by CYGNUS MEDICAL L.L.C.

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• 10843356102731 - CYGNUS: 2024-03-04 12"x18" Tray Liner 50 parts per bag
• 10843356102700 - Air Time: 2024-02-09 AIRTIME™ HORIZONTAL DRYING, DIRECTIONAL FLOW TUBING SET. USED FOR DRYING COILED SCOPES. 4 TUBING PORTS
• 30843356100649 - SingleCycle Biohazard Self-Sealing label 20": 2023-12-08 SingleCycle Biohazard Self-Sealing label 20" 500 per case
• 30843356102391 - SingleCycle Biohazard Self-Sealing label 15": 2023-12-08SingleCycle Biohazard Self-Sealing label 15" 500 per case
• 30843356102391 - SingleCycle Biohazard Self-Sealing label 15": 2023-12-08 SingleCycle Biohazard Self-Sealing label 15" 500 per case