SK PODO 0.394 in (10 mm) pointed orange - coarse

Basic Information

• Brand Name: SK PODO 0.394 in (10 mm) pointed orange - coarse
• Primary DI: 14027497276681
• Version / Model: A611001030800061
• Catalog Number: A611001030800061
• Company Name: LUKAS-ERZETT GmbH & Co. KG
• Labeler DUNS: 329277813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2026-02-10
• Public Version: 1
• Public Version Date: 2026-02-18
• Public Version Status: New
• Public Device Record Key: f90b2980-4ebd-4536-b97b-95ef0f680222

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64025	Podiatric bur, single-use	A rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. 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	04027497276684	GS1
Primary	14027497276681	GS1