Susol® Blacks File Double Ended Micro with Round Probe 14cm

Basic Information

• Brand Name: Susol® Blacks File Double Ended Micro with Round Probe 14cm
• Primary DI: 05060418834029
• Version / Model: SS08-0557
• Company Name: BAILEY INSTRUMENTS LTD
• Labeler DUNS: 769260357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-27
• Public Version: 1
• Public Version Date: 2024-03-06
• Public Version Status: New
• Public Device Record Key: 75b7cbba-8b8b-4e49-84c2-2fb37e4a3a8a

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65048	Podiatric probe, single-use	A hand-held manual surgical instrument designed for inspection or freeing of the nail bed and nail edges during a podiatric procedure. It is typically made of metal and includes a handle with a fine atraumatic tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060418832704	GS1	Pack	10	In Commercial Distribution
Primary	05060418834029	GS1