FDA.report

endophix

Primary DI
06974940306604
Brand
endophix
Company
Suzhou Endophix Co., Ltd.
Model
MS-3206
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974940306604PrimaryGS10

GMDN Terms

TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
620899345
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
06974940306727endophixMS-15252026-03-03
06974940306758endophixMS-15292026-03-03
06974940306772endophixMS-1535T2026-03-03
06974940306857endophixMS-1529-12026-03-03
06974940306864endophixMS-1529-22026-03-03
06974940306918endophixMS-1525-32026-03-03
06974940307007endophixMS-1529-32026-03-03
06974940307021endophixMS-1525-12026-03-03
06974940307038endophixMS-1525-22026-03-03
06974940307045endophixMS-430620S2025-12-19
06974940307052endophixMS-430820S2025-12-19
06974940307069endophix MS-430840S2025-12-19
06974940307076endophix MS-430860S2025-12-19
06974940307083endophixMS-431020S2025-12-19
06974940307090endophixMS-431050S2025-12-19
06974940306321endophixMS-32022025-12-12
06974940306352endophixMS-32032025-12-12
06974940306369endophixMS-32042025-12-12
06974940306468endophixMS-32052025-12-12
06974940306611endophixMS-32122025-12-12

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