Endo-Ease Lubricant

Basic Information

• Brand Name: Endo-Ease Lubricant
• Primary DI: 00867630000233
• Version / Model: EEL-400
• Catalog Number: EEL-400
• Company Name: SPIRUS MEDICAL LLC
• Labeler DUNS: 969696975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a602804b-3367-4568-911c-c15d61ec464a

Device Description

A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867630000233	GS1
Package	40867630000200	GS1	box	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080042	000