N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00840329833794
• Version / Model: B86026E
• Catalog Number: B86026E
• Company Name: BLACK & BLACK SURGICAL, INC.
• Labeler DUNS: 004382282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-17
• Public Version: 1
• Public Version Date: 2023-11-27
• Public Version Status: New
• Public Device Record Key: ee1bcf79-0c13-4624-859d-9cc196b18f69

Device Description

HARD PEDAL, 10FT TUBING FOR EUROMI

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58029	Foot-switch, pneumatic	A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840329833794	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]