Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058084278
• Version / Model: 8427
• Catalog Number: 8427
• Company Name: ROBINSON HEALTHCARE LIMITED
• Labeler DUNS: 237799775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-23
• Public Version: 2
• Public Version Date: 2026-02-12
• Public Version Status: Update
• Public Device Record Key: b685d06a-86df-4b42-aed9-fbeef2d0ab2e

Device Description

Instrapac Podiatry Basic Instrument Pack - Small Curved Roller Spring X 20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58940	Podiatry kit, single-use	A collection of devices intended for treatment of cutaneous foot disorders such as hardened skin, corns, and ingrown/ingrowing toenails. It typically consists of two or more of the following items: nail cutters, nail file, dermal curette, scalpel handle and blades, probe, gauze applicators, and/or dressings (e.g., coverings, protection/treatment solutions); it may be used in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058184275	GS1	Box	20	In Commercial Distribution
Primary	05010058084278	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep out of direct sunlight