LeGoo® LG250

Basic Information

• Brand Name: LeGoo® LG250
• Primary DI: 20358468019046
• Version / Model: LG250
• Company Name: GENZYME CORPORATION
• Labeler DUNS: 078893293
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7a1f576e-a95c-40ea-905c-a0e6e2ea88d8
• Distribution End Date: 2016-06-30

Device Description

Occluder, Internal Vessel, Temporary

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: No
• 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
OBC	Occluder, internal vessel, temporary	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47043	Intravascular occluding solution kit	A collection of sterile devices intended as an alternative to vascular clamping to interrupt local blood flow through transient intraluminal obstruction during surgery, suturing of blood vessels, or interventional vascular procedures. It includes a liquid polymer (e.g., poloxamer) that is injected into a vein/artery, and devices to contain/administer the solution (e.g., pouch, syringe, injection cannula or catheter). The solution typically has reverse thermal characteristics (i.e., liquid at room temperature and gelled at body temperature) enabling the formation of an in vivo plug that occludes the vessel; it eventually dissolves or is purposely dissolved. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20358468019046	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			one 2.5 mL syringe with 1 cannula (3.0 x 80 mm)
Total Volume	2.5	Milliliter

Storage Conditions

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