FDA.reportPublic FDA data

HydroPearl

Primary DI
00812636020648
Brand
HydroPearl
Company
Microvention, Inc.
Model
8HP2S600
Catalog number
8HP2S600
Device description
Bland Beads
Published
2018-08-07
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
NAJAgents, embolic, for treatment of uterine fibroids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150870000HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.2015-12-21KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812636020648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812636020648008126360206488126360206480812636020648

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA sterile, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810563021066Embozene Color Advance 40um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021073Embozene Color Advance 75um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021080Embozene Color Advance 100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021097Embozene Color Advance 250um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021103Embozene Color Advance 400um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021110Embozene Color Advance 500um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021127Embozene Color Advance 700um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021134Embozene Color Advance 900um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021141Embozene Color Advance 1100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021158Embozene Color Advance 1300um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021424ONCOZENE 40um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021431ONCOZENE 40um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021448ONCOZENE 75um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021455ONCOZENE 75um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021462ONCOZENE 100um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021479ONCOZENE 100um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021486Embozene Color Advance 40um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021493Embozene Color Advance 75um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021509Embozene Color Advance 100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021516Embozene Color Advance 250um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021523Embozene Color Advance 400um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021530Embozene Color Advance 500um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021547Embozene Color Advance 700um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021554Embozene Color Advance 900um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021561Embozene Color Advance 1100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021578Embozene Color Advance 1300um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00884450403716Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450403822Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450299432Embosphere®BIOSPHERE MEDICALNAJ2022-09-20
10884450299439Embosphere®BIOSPHERE MEDICALNAJ2022-09-20