Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058088498
• Version / Model: 8849
• Catalog Number: 8849
• Company Name: ROBINSON HEALTHCARE LIMITED
• Labeler DUNS: 237799775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 1
• Public Version Date: 2022-08-22
• Public Version Status: New
• Public Device Record Key: c8bab6cf-6603-4bd9-abf6-4e04a8b842d4

Device Description

Instrapac Jobson Horne Probe 12.5cm/5in X 50

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
JYH	EXCAVATOR, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63876	Endaural surgical curette, single-use	A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058188495	GS1	Box	50	In Commercial Distribution
Primary	05010058088498	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	12.5	Centimeter

Storage Conditions

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