FDA.reportPublic FDA data

endophix

Primary DI
06974940306307
Brand
endophix
Company
Suzhou Endophix Co., Ltd.
Model
MS-3119-04
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974940306307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974940306307069749403063076974940306307

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
620899345
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974940307236endophixMS-3107-022026-06-23
06974940307243endophixMS-31082026-06-23
06974940307830endophixMS-20032026-06-23
06974940307878endophixMS-2025-122026-06-23
06974940305188endophixMS-2025PS-62026-04-28
06974940305195endophixMS-2025PS-72026-04-28
06974940305201endophixMS-2025PS-82026-04-28
06974940305218endophixMS-2025PS-92026-04-28
06974940305225endophixMS-2025PS-102026-04-28
06974940305232endophixMS-2025PS-112026-04-28
06974940305249endophixMS2025PW-62026-04-28
06974940305256endophixMS2025PW-82026-04-28
06974940305263endophixMS2025PW-102026-04-28
06974940305270endophixMS2025PW-122026-04-28
06974940305454endophixMS-1120N2026-04-28
06974940305461endophixMS-1128N2026-04-28
06974940305478endophixMS-1128-1N2026-04-28
06974940305485endophixMS-1135N2026-04-28
06974940305492endophixMS-1150N2026-04-28
06974940305508endophixMS-1165N2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10