Home GUDID 00810563021516 Embozene Color Advance 250um Embozene 1mL Colored - US
Primary DI 00810563021516
Brand Embozene Color Advance 250um Embozene 1mL Colored - US
Company Varian Medical Systems, Inc.
Model 12010-S1
Published 2023-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Sterile true
Single use true Product Codes# Code, Name table Code Name KRD Device, Vascular, for Promoting Embolization NAJ Agents, embolic, for treatment of uterine fibroids NOY Agents, embolic, for treatment of benign prostatic hyperplasia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2 NAJ Agents, Embolic, For Treatment Of Uterine Fibroids Cardiovascular 2 NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810563021516 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 00810563021516 00810563021516 810563021516 0810563021516
GMDN Terms# Term, Definition table Term Definition Embolization particle, non-bioabsorbable A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
Regulatory Flags# DUNS number 118097024 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816389028081 MAASTRO Rectal Applicator Set, ø 26 mm GM11014100 GM11014100 2026-06-02 00816389020191 Applicator and Dilator for Proctoscope ø26 mm GM11014310 GM11014310 2026-05-26 00816389020207 Applicator and Dilator for Proctoscope ø30 mm GM11014410 GM11014410 2026-05-26 00816389028098 Applicator ø 20 mm, for Proctoscope ø 26 mm GM11014110 GM11014110 2026-05-26 00816389028104 Proctoscope ø 26 mm GM11014120 GM11014120 2026-05-26 00816389028111 Dilator for Proctoscope ø 26 mm GM11014130 GM11014130 2026-05-26 00816389028128 Illumination Adapter for Proctoscope ø 26 mm GM11014150 GM11014150 2026-05-26 00816389028135 Fixation Screw GM11014160 GM11014160 2026-05-26 00816389028142 MAASTRO Rectal Applicator Set, ø 30 mm GM11014200 GM11014200 2026-05-26 00816389028159 Applicator ø 24 mm, for Proctoscope ø 30 mm GM11014210 GM11014210 2026-05-26 00816389028166 Proctoscope ø 30 mm GM11014220 GM11014220 2026-05-26 00816389028173 Dilator for Proctoscope ø 30 mm GM11014230 GM11014230 2026-05-26 00816389028180 Illumination Adapter for Proctoscope ø 30 mm GM11014250 GM11014250 2026-05-26 00816389028999 Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mm GM11014170 GM11014170 2026-05-26 00816389029002 Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mm GM11014270 GM11014270 2026-05-26 00850800006074 Vitesee 5.0 Vitesse 5.0 2024-11-01 00810563022032 ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal PC-2.1E 2023-04-20 00810563022049 ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical PC-2.1S 2023-04-20 00810563022056 ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal PC-2.1EL 2023-04-20 00810563022063 ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical PC-2.1SL 2023-04-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000495619 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000495640 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 07613327578577 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578591 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578607 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578638 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578676 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578683 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578690 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578706 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578737 Target Tetra Stryker Corporation KRD 2022-12-19 07613327578744 Target Tetra Stryker Corporation KRD 2022-12-19 07613327580099 Target Tetra Stryker Corporation KRD 2022-12-19 00763000488673 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488703 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488949 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000489182 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000489250 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000489281 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000489328 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 07613327466386 TARGET Stryker Corporation KRD 2019-09-05 07613327466416 TARGET Stryker Corporation KRD 2019-09-05 07613327466423 TARGET Stryker Corporation KRD 2019-09-05 00847536033085 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033122 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033146 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033221 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033382 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033405 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29 00847536033429 AxiumTM Micro Therapeutics, Inc. KRD 2019-06-29