FDA.reportPublic FDA data

Accurian

Primary DI
00763000171209
Brand
Accurian
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
ASG001
Device description
GENERATOR ASG001 REFURBISHED
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGENERATOR, LESION, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181864000Polaris RF Ablation SystemBaylis Medical Company, Inc.2019-01-02GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000171209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000171209007630001712097630001712090763000171209

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system generatorA mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between -20°C and 60°C, Rel. Humidity 20% - 95% non-condensing

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150072668Medtronic Reusable InstrumentsEX20260152026-08-09
00199150083459Medtronic Reusable InstrumentsEX65500002026-08-08
00199150083466Medtronic Reusable InstrumentsEX65500062026-08-08
00199150076468Medtronic Reusable InstrumentsX46810082026-08-03
00199150076475Medtronic Reusable InstrumentsX46820082026-08-03
00199150076482Medtronic Reusable InstrumentsX46800202026-08-03
00199150076499Medtronic Reusable InstrumentsX46800212026-08-03
00199150083473Medtronic Reusable InstrumentsEX75709002026-08-03
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy System4361254002026-08-01
00763000992026MSB CD HORIZON Spinal SystemX04150662026-08-02
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
10195327563424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
05415067034519N/AST. JUDE MEDICAL, INC.GXD2023-10-25
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00825114000032OWLDiros Technology IncGXD2023-06-19
00852454006288RelievantRelievant Medsystems, Inc.GXD2022-12-09
00193493000692COOLIEF* Quad Pump Connector CableAvanos Medical, Inc.GXD2022-10-17
00193493000340AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000357AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000401AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493000418AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF* Basic-R GeneratorAvanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF* Cooled RF Advanced-R GeneratorAvanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11