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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVGEmbolization Agent, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVGEmbolization Agent, VascularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250003000
P250003001
P250003004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250003000Embrace(TM) Hydrogel Embolic SystemInstylla, Inc.2025-08-05QVG
P250003001Embrace(TM) Hydrogel Embolic SystemInstylla, Inc.2025-08-05QVG
P250003004Embrace(TM) Hydrogel Embolic SystemInstylla, Inc.2025-08-05QVG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812013030215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812013030215008120130302158120130302150812013030215

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, bioabsorbableA bioabsorbable, implantable bead/microsphere intended to be used to temporarily occlude an artery supplying hyperplastic/neoplastic tissue in a variety of anatomies (e.g., liver, lung, breast, bladder, uterus, head or neck); it does not include a pharmaceutical agent. It may be used independently to create ischemia in the tissue, or as an adjuvant in combination with cytostatic agents and other antitumour drugs to help optimize intra-tumour drug accumulation for interventional radiology and visceral surgery procedures. It is typically available as an injectable solution containing numerous microspheres [e.g., degradable starch microspheres (DSM)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-790-4860xx@xx.xx

Regulatory Flags#

DUNS number
081009360
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812013030291Instylla Delivery KitINS90-3001-0072026-03-25
00812013030116Instylla Delivery KitINS90-3001-007N/A2025-09-18
00812013030086Instylla Microcatheter 1.2INS90-2001-007N/A2021-09-07
00812013030093Instylla Microcatheter 1.2INS90-2001-008N/A2021-09-07
00812013030109Instylla Microcatheter 1.2INS90-2001-0092021-09-07
00812013030048Instylla MicrocatheterINS90-2001-004N/A2020-11-20
00812013030055Instylla MicrocatheterINS90-2001-005N/A2020-11-20
00812013030062Instylla MicrocatheterINS90-2001-006N/A2020-11-20
00812013030000Instylla Delivery KitINS90-3001-002N/A2020-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850055697003LAVA-18, 2 mLSirtex Medical Inc.QVG2023-10-23
00850055697010LAVA-34, 2 mLSirtex Medical Inc.QVG2023-10-23
00850055697027LAVA-18, 6 mLSirtex Medical Inc.QVG2023-10-23
00850055697034LAVA-34, 6 mLSirtex Medical Inc.QVG2023-10-23
00850055697041LAVA Mixing Kit, 2 mLSirtex Medical Inc.QVG2023-10-23
00850055697058LAVA Mixing Kit, 6 mLSirtex Medical Inc.QVG2023-10-23