FDA.reportPublic FDA data

Disc-FX® Guidewire

Primary DI
00846338001322
Brand
Disc-FX® Guidewire
Company
ELLIQUENCE, LLC
Model
DFX-GW-S/1
Published
2018-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338001322PackageGS110In Commercial Distribution
00846338010911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338001322008463380013228463380013220846338001322
00846338010911008463380109118463380109110846338010911

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
019872358
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338003869Surgi-Max Drill16-02002026-05-11
00846338003876Surgi-Max Drill16-02012026-05-11
00846338004422Trigger-Flex Quad Pro Bipolar SystemDTFQM-132026-05-11
00846338004439Trigger-Flex Quad Pro Bipolar SystemDTFQM-342026-05-11
00846338004446Trigger-Flex Quad Pro Bipolar SystemDTFQM-352026-05-11
00846338004453Trigger-Flex Quad Pro Bipolar SystemDTFQM-362026-05-11
00846338004460Trigger-Flex Quad Pro Bipolar SystemDTFQM-382026-05-11
00846338004477Trigger-Flex Quad Pro Bipolar SystemDTFQM-392026-05-11
00846338004484Bipolar Forceps J12026-05-11
00846338004491COBBRARF-COBB/XL2026-05-11
00846338004507COBBRARF-COBB/S2026-05-11
00846338004514COBBRARF-COBB/XS2026-05-11
00846338004521Endiscope10-20162026-05-11
00846338004538Endiscope10-20172026-05-11
00846338004545Endiscope10-20182026-05-11
00846338004552Endiscope10-20192026-05-11
00846338004569Endiscope10-20242026-05-11
00846338004576Endiscope10-20252026-05-11
00846338004583Endiscope10-20262026-05-11
00846338004590Endiscope10-20272026-05-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056336SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056343SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-31
08800038056145SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056176SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056183SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-19
08800038055643SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2023-08-30
08800104089473Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
08800104089480Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
07613327554663OmnicurveSTRYKER CORPORATIONHRX2022-04-12