FDA.report

Biosense Webster

Primary DI
08718375860052
Brand
Biosense Webster
Company
Technomed Engineering B.V.
Model
C6FFMST10
Device description
D-1221-12-S / 39F-52R non-autoclavable conn. cable
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718375860052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08718375860052087183758600528718375860052

GMDN Terms

TermDefinition
Analytical non-scalp cutaneous leadAn insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags

DUNS number
418415568
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08720791377700Inomed5256202025-12-10
08720791377717Inomed5256212025-12-10
08720791377724Inomed5256222025-12-10
08720791377731Inomed5256232025-12-10
08720791377847Inomed5200482025-12-10
08720791378530Cadwell302882-0002025-12-10
08720791378554Technomed EuropeTE/C52-4382025-11-11
08720791378561Technomed EuropeTE/C52-6382025-11-11
08720791378578Technomed EuropeTE/C52-8382025-11-11
08720791378585Technomed EuropeTE/C52-9382025-11-11
08720791378592Technomed EuropeTE/C53-4382025-11-11
08720791378608Technomed EuropeTE/C53-6382025-11-11
08720791378615Technomed EuropeTE/C53-8382025-11-11
08720791378622Technomed EuropeTE/C53-9382025-11-11
08720791378011Cadwell302862-000-GP22025-07-16
08720791378035Cadwell302864-000-GP22025-07-15
08720791377656Cadwell302906-0002025-05-26
08720791377670Cadwell302907-0002025-05-26
08720791375911Cadwell302881-0002025-03-12
08720791374587Neurosign4000-002025-02-28

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