FDA.reportPublic FDA data

1.9mm Arthroscope, 30°, Autoclavable

Primary DI
M9575012000
Brand
1.9mm Arthroscope, 30°, Autoclavable
Company
Nexus Cmf, L.L.C.
Model
501200
Published
2020-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M9575012000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags#

DUNS number
965540227
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M957500092055mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000922014-11-11
M9575001090Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)5001092014-10-15
M957500090045mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000902014-11-11
M957500091050mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000912014-11-11
M9575001100Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)5001102014-10-15
M95750042302.7 x 10.0 mm screws [7]5004232014-11-11
M95750009502.0 × 10.0 mm Screw5000952014-11-11
M95750009902.7 × 8.0 mm Screw5000992014-11-11
M95750010002.7 × 10.0 mm Screw5001002014-11-11
M95750010102.7 × 12.0 mm Auxiliary Screw5001012014-11-11
M95750010203.0 × 8.0 mm Auxiliary Screw5001022014-11-11
M95750010303.0 × 10.0 mm Auxiliary Screw5001032014-11-11
M95750010403.0 × 12.0 mm Auxiliary Screw5001042014-11-11
M95750011202.7x8.0mm [2] & 2.7x10.0mm [5] Screws5001122016-09-02
M95750042002.0 x 6.0 mm screws [5]5004202014-11-11
M95750042102.0 x 8.0 mm screws [5]5004212014-11-11
M95750009302.0 × 6.0 mm Screw5000932014-11-11
M95750009402.0 × 8.0 mm Screw5000942014-11-11
M95750009702.3 × 8.0 mm Auxiliary Screw5000972014-11-11
M95750009802.3 × 10.0 mm Auxiliary Screw5000982014-11-11

Other Devices Sharing Product Codes#

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