FDA.report

iCONNECT - AMPERE

Primary DI
04044508137031
Brand
iCONNECT - AMPERE
Company
OSYPKA GmbH
Model
82066
Catalog number
001-009079-1
Device description
The system cables are used for the connection of different systems to the iCONNECT connection hub.
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LPBCardiac Ablation Percutaneous Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions

SubmissionSupplement
P240014000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P240014000MAGiC Ablation CatheterStereotaxis, Inc.2026-01-05LPB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04044508137031PackageGS11In Commercial Distribution
04044508137048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04044508137031040445081370314044508137031
04044508137048040445081370484044508137048

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes

TypeValueUnit
Length132Centimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
316276799
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04044508136959MAGIC - iCONNECT82062001-009074-12026-03-13
04044508152218MAGiC Magnetic Interventional Ablation Catheter8C-21-031Z-B001-009740-22026-03-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
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