FDA.reportPublic FDA data

Bearing nsPVA®

Primary DI
10884450123369
Brand
Bearing nsPVA®
Company
Merit Medical Systems, Inc.
Model
00884450123362
Catalog number
V800EP
Published
2015-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450123369PackageGS15In Commercial Distribution
00884450123362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445012336910884450123369
00884450123362008844501233628844501233620884450123362

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

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

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