Home GUDID 00812013030215 Embrace Hydrogel Embolic System (HES)
Primary DI 00812013030215
Brand Embrace Hydrogel Embolic System (HES)
Company INSTYLLA INC.
Model INS90-4001-003
Published 2025-12-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QVG Embolization Agent, Vascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVG Embolization Agent, Vascular Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812013030215 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812013030215 00812013030215 812013030215 0812013030215
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization plug, synthetic polymer, bioabsorbable A bioabsorbable device intended to be implanted in a peripheral (non-neurovascular) artery to temporarily obstruct blood flow typically for embolization of hypervascular tumours (e.g., nephroma, hepatoma, uterine fibroids). It is in the form of an injectable synthetic polymer hydrogel [e.g., made of polyethylene glycol (PEG)] that solidifies in situ to form a coherent embolus requiring no thrombosis to create blockage. It is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 081009360 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00812013030291 Instylla Delivery Kit INS90-3001-007 2026-03-25 00812013030116 Instylla Delivery Kit INS90-3001-007 N/A 2025-09-18 00812013030086 Instylla Microcatheter 1.2 INS90-2001-007 N/A 2021-09-07 00812013030093 Instylla Microcatheter 1.2 INS90-2001-008 N/A 2021-09-07 00812013030109 Instylla Microcatheter 1.2 INS90-2001-009 2021-09-07 00812013030000 Instylla Delivery Kit INS90-3001-002 N/A 2020-11-20 00812013030048 Instylla Microcatheter INS90-2001-004 N/A 2020-11-20 00812013030055 Instylla Microcatheter INS90-2001-005 N/A 2020-11-20 00812013030062 Instylla Microcatheter INS90-2001-006 N/A 2020-11-20
Other Devices Sharing Product Codes# 
xx.xx