Home GUDID 00840303712107
Prestige Coil System
Primary DI 00840303712107
Brand Prestige Coil System
Company BALT USA LLC
Model PRESPACK55
Catalog number N/A
Device 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.
Published 2026-07-14
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name KRD Device, Vascular, For Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840303712107 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840303712107 00840303712107 840303712107 0840303712107
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at a controlled room temperature in a dry place.
Regulatory Flags# DUNS number 945543689 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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840303712053 Prestige Coil System PRESPACK30 N/A 2026-07-14 00840303712077 Prestige Coil System PRESPACK65 N/A 2026-07-14 00840303712091 Prestige Coil System PRESPACK55 N/A 2026-07-14 00840303714521 Optima Coil System (OptiOne Coil System) OPTIONE4S N/A 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) OPTIONE4M N/A 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) OPTIONE4L N/A 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) OPTIONE45S N/A 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) OPTIONE45M N/A 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) OPTIONE45L N/A 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) OPTIONE5S N/A 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) OPTIONE5M N/A 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) OPTIONE5L N/A 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) OPTIONE5XL N/A 2026-07-06 00840303714620 Optima Coil System (OptiOne Coil System) OPTIONE55S N/A 2026-07-06 00840303714637 Optima Coil System (OptiOne Coil System) OPTIONE55M N/A 2026-07-06 00840303714644 Optima Coil System (OptiOne Coil System) OPTIONE55L N/A 2026-07-06 00840303714651 Optima Coil System (OptiOne Coil System) OPTIONE55XL N/A 2026-07-06 00840303714668 Optima Coil System (OptiOne Coil System) OPTIONE6S N/A 2026-07-06 00840303714675 Optima Coil System (OptiOne Coil System) OPTIONE6M N/A 2026-07-06 00840303714682 Optima Coil System (OptiOne Coil System) OPTIONE6L N/A 2026-07-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840303712053 Prestige Coil System BALT USA LLC KRD 2026-07-14 00840303712077 Prestige Coil System BALT USA LLC KRD 2026-07-14 00840303712091 Prestige Coil System BALT USA LLC KRD 2026-07-14 06958698053355 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053362 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053379 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053386 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053393 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053409 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053416 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053423 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053430 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053447 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053454 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053461 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053478 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053485 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053492 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053508 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 07613327635096 InZone IST Stryker Corporation KRD 2026-07-08 00840303714521 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06