FDA UDI
In Commercial Distribution
🇺🇸 United States
Prestige Coil System
DI: 00818053027697
·
Model: PRES0407CRG10
·
BALT USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prestige Coil System
- Primary DI
- 00818053027697
- Version / Model
- PRES0407CRG10
- Company Name
- BALT USA LLC
- Labeler DUNS
- 945543689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-04
- Public Version
- 1
- Public Version Date
- 2021-10-12
- Public Version Status
- New
- Public Device Record Key
- ca250689-743b-4bc9-b9a6-cab27acacce1
Device Description
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 60941 | Non-neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818053027697 | GS1 |
Customer Contacts
- Phone
- 1-949-788-1443
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200030 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at a controlled room temperature in a dry place.