FDA.reportPublic FDA data

RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder)

Primary DI
08058341218716
Brand
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder)
Company
ITALIAN ENGINEERING SRL
Model
RF0MXXYYYRZZ
Device description
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm without Holder.This includes:- RF0M22050R10- RF0M22100R10- RF0M20150R10- RF0M16200R10.Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. They are to be used only with ATTIVA device (K220505).
Published
2023-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220505000ATTIVAItalian Engineering S.R.L.2023-02-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058341218716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341218716080583412187168058341218716

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431954955
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055510890131RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder)RF0M22100R10A2023-08-04
08058341213919RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)RF0MXXYYYRZZA2023-03-28
05060224333983RF THERMOCOUPLE ELECTRODERFEL-R50-IE2023-03-28
05060224333990RF THERMOCOUPLE ELECTRODERFEL-R100-IE2023-03-28
05060224334003RF THERMOCOUPLE ELECTRODERFEL-R150-IE2023-03-28
05060224334010RF THERMOCOUPLE ELECTRODERFEL-R200-IE2023-03-28
05060224334072INTERMEDIATE CABLECBEL-R-IE2023-03-20
08055510890087ATTIVAMD012023-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
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08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16