Identity
- Trade Name
- Prestige Coil System FDA UDI
- Generic Name
- Non-neurovascular embolization coil FDA UDI
- Device Name
- The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Prestige Packing Coil delivery pusher is 185cm in length. It is designed for use with the Ultra Detachment Controller. The Ultra Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Prestige Packing Coil and Ultra Detachment Controller(s) are sold separately. The Prestige Packing Coil achieves detachment by an internal heater element, which is powered by the Ultra Detachment Controller. FDA UDI
- Model / Reference
- PRESPACK15 FDA UDI
- Description
- The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Prestige Packing Coil delivery pusher is 185cm in length. It is designed for use with the Ultra Detachment Controller. The Ultra Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Prestige Packing Coil and Ultra Detachment Controller(s) are sold separately. The Prestige Packing Coil achieves detachment by an internal heater element, which is powered by the Ultra Detachment Controller. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00840303712022 FDA UDI
- 510(k) Number
- K251383 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Non-neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Non-neurovascular embolization coil
Prestige Coil System by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-neurovascular embolization coil.
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Cleared under the same submission
K251383 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Balt Usa Llc
Sources (1)
- FDA UDI c5b24481-0211-4fce-9371-42fc03851dea 38 fields · synced May 31, 2026