LeGoo® LG100

GUDID 20358468019039

Occluder, Internal Vessel, Temporary

GENZYME CORPORATION

Intravascular occluding solution kit

• Primary Device ID: 20358468019039
• NIH Device Record Key: ac52ba98-89a0-4cf3-a9be-b59a80bdeeb3
• Commercial Distribution Discontinuation: 2016-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LeGoo® LG100
• Version Model Number: LG100
• Company DUNS: 078893293
• Company Name: GENZYME CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)661-1471
• Email: brian.nelson@genzyme.com
• Phone: +1(508)661-1471
• Email: brian.nelson@genzyme.com

Device Dimensions

• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20358468019039 [Primary]

FDA Product Code

• OBC: Occluder, internal vessel, temporary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

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• 00358468664112 - Seprafilm® Single Site: 2019-09-10 Barrier, Absorbable, Adhesion
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