Embrace Hydrogel Embolic System (HES)

GUDID 00812013030215

Instylla Inc.

Embolization particle, bioabsorbable

• Primary Device ID: 00812013030215
• NIH Device Record Key: 4dc7eac8-a314-42f6-9cd0-7a39f893de2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embrace Hydrogel Embolic System (HES)
• Version Model Number: INS90-4001-003
• Company DUNS: 081009360
• Company Name: Instylla Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812013030215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250003

FDA Product Code

• QVG: Embolization Agent, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by Instylla Inc.

• 00812013030215 - Embrace Hydrogel Embolic System (HES): 2025-12-09
• 00812013030215 - Embrace Hydrogel Embolic System (HES): 2025-12-09
• 00812013030116 - Instylla Delivery Kit: 2025-09-26
• 00812013030086 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030093 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030109 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030000 - Instylla Delivery Kit: 2020-11-30 N/A
• 00812013030048 - Instylla Microcatheter: 2020-11-30 N/A
• 00812013030055 - Instylla Microcatheter: 2020-11-30 N/A