Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058071230
• Version / Model: 7123
• Catalog Number: 7123
• Company Name: ROBINSON HEALTHCARE LIMITED
• Labeler DUNS: 237799775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 0e9e9d8d-ea8d-4fef-82b9-a32a4c6fa3f2

Device Description

Instrapac Dental Conservation Pack 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: No
• 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
NYC	Dental Prophylaxis Kit	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45148	Dental/maxillofacial surgical procedure kit, non-medicated, single-use	A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058171237	GS1	Box	40	In Commercial Distribution
Primary	05010058071230	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