FDA.reportPublic FDA data

NA

Primary DI
04546540904874
Brand
NA
Company
STRYKER CORPORATION
Model
0406850105
Catalog number
0406-850-105
Device description
Connecting Cable
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIPROBE, RADIOFREQUENCY LESION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540904874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540904874045465409048744546540904874

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).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14895233602366LCCSLCCS Products LimitedGXI2025-11-17
00856895008153One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-09-01
00856895008139One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00856895008146One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2025-08-20
00852454006424IntraceptRelievant Medsystems, Inc.GXI2025-08-04
00825114014879OWLDiros Technology IncGXI2025-07-16
04048223131947RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223131954RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132005RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132340TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132357TLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132470RFTL SonoPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132647RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132692RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223132715RFTLPajunk GmbH MedizintechnologieGXI2025-06-17
04048223049709RGNPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050132RFTLPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050484RFTL SonoPajunk GmbH MedizintechnologieGXI2025-01-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
40195327666355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SCV181505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV201515Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV220510Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
M661SCV221005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18