SingleCycle Biohazard Self-Sealing label 25"

Basic Information

• Brand Name: SingleCycle Biohazard Self-Sealing label 25"
• Primary DI: 00843356102420
• Version / Model: SCB25
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-11-30
• Public Version: 1
• Public Version Date: 2023-12-08
• Public Version Status: New
• Public Device Record Key: b45e2d43-bbed-4d11-a086-b75e53ea1506

Device Description

SingleCycle Biohazard Self-Sealing label 25" 500 per case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PXV	General Purpose Instrument Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63406	Device operating status label/tag, single-use	A label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30843356102421	GS1
Primary	00843356102420	GS1