LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. (UDI Z-2155-2013)
Manufactured by Genzyme Corporation, A Sanofi Company
Device Regulatory Overview
The LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. (Model/Catalog Number: Unspecified) is a medical device manufactured by Genzyme Corporation, A Sanofi Company. This product is indexed under FDA Product Code / Category Classification All lot codes within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- All lot codes
- Device Name
- LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
- Database Sync Date
- 2026-08-09 10:06:42
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.?
The registered manufacturer of record for LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. is Genzyme Corporation, A Sanofi Company.
What is the Primary UDI-DI identifier for LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2155-2013.
What classification code is assigned to this device?
This device is registered under product classification code All lot codes.
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Other Devices by Genzyme Corporation, A Sanofi Company
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- → LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
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