Surgilube

Basic Information

• Brand Name: Surgilube
• Primary DI: 00851809002463
• Version / Model: 281020555
• Catalog Number: 281020555
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 0cb0fdd6-53bb-49fb-af97-7408137d5c5b

Device Description

Sterile Surgical Lubricant, Metal Tube

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMJ	Lubricant, patient	General Hospital	880.6375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60796	General-body orifice lubricant	A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	No	Active
60795	Multi-purpose surgical instrument lubricant	A sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30851809002464	GS1	Case	4	In Commercial Distribution
Package	20851809002467	GS1	Carton	3	In Commercial Distribution
Package	10851809002460	GS1	Box	48	In Commercial Distribution
Primary	00851809002463	GS1

Customer Contacts

• Phone: [phone] ext. 109
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	5	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius