Bearing nsPVA®
- Primary DI
- 10884450123352
- Brand
- Bearing nsPVA®
- Company
- Merit Medical Systems, Inc.
- Model
- 00884450123355
- Catalog number
- V600EP
- Published
- 2015-10-30
- 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 |
|---|
| NAJ | AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10884450123352 | Package | GS1 | 5 | In Commercial Distribution |
| 00884450123355 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10884450123352 | 10884450123352 | | |
| 00884450123355 | 00884450123355 | 884450123355 | 0884450123355 |
GMDN Terms
| Term | Definition |
|---|
| Embolization particle, non-bioabsorbable | A 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 |
|---|
| Device Size Text, specify | 0 | |
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
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|---|
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| 00810563021097 | Embozene Color Advance 250um Embozene 2mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021110 | Embozene Color Advance 500um Embozene 2mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021424 | ONCOZENE 40um Oncozene 2mL - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021455 | ONCOZENE 75um Oncozene 3mL - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021509 | Embozene Color Advance 100um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021516 | Embozene Color Advance 250um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021547 | Embozene Color Advance 700um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021554 | Embozene Color Advance 900um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021561 | Embozene Color Advance 1100um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
| 00810563021578 | Embozene Color Advance 1300um Embozene 1mL Colored - US | VARIAN MEDICAL SYSTEMS, INC. | NAJ | 2023-05-19 |
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