FDA UDI
In Commercial Distribution
🇺🇸 United States
HARBOR
DI: 00850072397580
·
Model: 04-OCCLUDE-070
·
Nuvascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HARBOR
- Primary DI
- 00850072397580
- Version / Model
- 04-OCCLUDE-070
- Catalog Number
- 04-OCCLUDE-070
- Company Name
- Nuvascular, Inc.
- Labeler DUNS
- 119270166
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-30
- Public Version
- 1
- Public Version Date
- 2025-08-07
- Public Version Status
- New
- Public Device Record Key
- 78badbe6-c52b-491d-b3ea-b8dc2b70ecc4
Device Description
HARBOR Occlusion Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61632 | Non-neurovascular embolization plug, metallic | A non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850072397580 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250133 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Vessel Diameter 7.0 mm |