miniRUMEL™

Basic Information

• Brand Name: miniRUMEL™
• Primary DI: 00850200006582
• Version / Model: 080130
• Catalog Number: 080130
• Company Name: LSI Solutions, Inc.
• Labeler DUNS: 603420183
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-03
• Public Version: 5
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: b6f875de-bbf8-4069-8df5-4cfc8d7c1f08
• Distribution End Date: 2020-10-09

Device Description

miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63420	Suture/ligature tightener, single-use	A hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850200006589	GS1	Inner pack	12	Not in Commercial Distribution	2020-10-09
Primary	00850200006582	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Minimum suture length required to use miniRUMEL™ Device.
Length	30	Inch