FDA UDI
In Commercial Distribution
🇺🇸 United States
HydroPearl
DI: 00816777026101
·
Model: HP2S0400
·
MICROVENTION INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HydroPearl
- Primary DI
- 00816777026101
- Version / Model
- HP2S0400
- Catalog Number
- HP2S0400
- Company Name
- MICROVENTION INC.
- Labeler DUNS
- 003263105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-07
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- c713d791-5786-4cd5-b7f4-5cfbb4add3c3
Device Description
Bland Beads
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAJ | Agents, embolic, for treatment of uterine fibroids | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60938 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816777026101 | GS1 |
Customer Contacts
- Phone
- +1(714)247-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150870 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 ml, 400 µm |