Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058078116
• Version / Model: 7811
• Catalog Number: 7811
• 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: 833a80f4-e69a-4d37-897a-01a099350ac5

Device Description

Instrapac Spoon Excavator Large X 40

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
EKC	Excavator, Dental, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64031	Dental excavator, single-use	A sterile, hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058178113	GS1	Box	40	In Commercial Distribution
Primary	05010058078116	GS1

Customer Contacts

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

Storage Conditions

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