Embrace Hydrogel Embolic System (HES)

Basic Information

• Brand Name: Embrace Hydrogel Embolic System (HES)
• Primary DI: 00812013030215
• Version / Model: INS90-4001-003
• Company Name: Instylla Inc.
• Labeler DUNS: 081009360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 2
• Public Version Date: 2026-03-26
• Public Version Status: Update
• Public Device Record Key: 4dc7eac8-a314-42f6-9cd0-7a39f893de2b

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: MR Safe
• Direct Marking Exempt: No
• 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
QVG	Embolization Agent, Vascular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
67704	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812013030215	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P250003	000
P250003	001
P250003	004

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – Degrees Celsius