FDA.reportPublic FDA data

STAR Tumor Ablation Kit (10 15, Long) with PowerCURVE

Primary DI
00850696006677
Brand
STAR Tumor Ablation Kit (10 15, Long) with PowerCURVE
Company
Dfine, Inc.
Model
RF-1015L-01
Catalog number
RF-1015L-01
Device description
blister tray packaging
Published
2016-08-23
Public version status
Update
Distribution status
Not 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
K091310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091310000ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682Dfine, Inc.2010-08-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850696006677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850696006677008506960066778506960066770850696006677

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
169957607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850696006004SpineSTAR Ablation Instrument (10 15, Long) STR-1015LSTR-1015L2016-08-23
00850696006011SpineSTAR Ablation Instrument (5 10, Long)STR-0510LSTR-0510L2016-08-23
00850696006240STAR Tumor Ablation Kit (10 15, Short) with PowerCURVERF-1015S-01RF-1015S-012016-08-23
00850696006257STAR Tumor Ablation Kit (5 10, Long) with PowerCURVERF-0510L-01RF-0510L-012016-08-23
00850696006264STAR Tumor Ablation Kit (5 10, Short) with PowerCURVERF-0510S-01RF-0510S-012016-08-23
00850696006271STAR Tumor Ablation Kit (10 15, Long) with PowerCURVERF-1015L-01RF-1015L-012016-08-23
00850696006646STAR Tumor Ablation Kit (5 10, Short) with PowerCURVERF-0510S-01RF-0510S-012016-08-23
00850696006653STAR Tumor Ablation Kit (5 10, Long) with PowerCURVERF-0510L-01RF-0510L-012016-08-23
00850696006660STAR Tumor Ablation Kit (10 15, Short) with PowerCURVERF-1015S-01RF-1015S-012016-08-23
00850696006684SpineSTAR Ablation Instrument (5 10, Short)354435442016-08-23
00850696006691SpineSTAR Ablation Instrument (10 15, Short)319231922016-08-23
00850696006028StabiliT Bone Cement and Saturate Mixing System445744572015-12-17
00850696006073StabiliT VP Fracture KitVP-0010AVP-0010A2015-12-11
00850696006226StabiliT First Fracture Kit 2003-12003-12015-11-02
00850696006233StabiliT First Fracture Kit 3353-013353-012016-01-27
00850696006288StabiliT MX Fracture Kit MX-2100L-01MX-1100S2015-11-30
00850696006295StabiliT MX Fracture Kit MX-2100S-01MX-1100S2015-11-30
00850696006301StabiliT MX Fracture Kit MX-1100L-01MX-1100S2015-11-30
00850696006318StabiliT MX Fracture Kit MX-1100S-01MX-1100S2015-11-30
00850696006370StabiliT Complete Fracture Kit 3506-013506-012016-03-23

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