FDA.reportPublic FDA data

Yonha

Primary DI
G503YHLM023
Brand
Yonha
Company
Changzhou Yonghua Medical Instruments Co ., Ltd.
Model
YHLM023
Device description
1.5 mm x 85mm Twist Drill Quick Connect
Published
2024-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G503YHLM023PrimaryHIBCC0

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
421329873
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
G503YHLM010YonhaYHLM0102024-01-06
G503YHLM012YonhaYHLM0122024-01-06
G503YHLM014YonhaYHLM0142024-01-06
G503YHLM015YonhaYHLM0152024-01-06
G503YHLM022YonhaYHLM0222024-01-06
G503YHLM007YonhaYHLM0072024-01-09
G503YHLM001YonhaYHLM0012024-01-06
G503YHLM002YonhaYHLM0022024-01-06
G503YHLM003YonhaYHLM0032024-01-06
G503YHLM004YonhaYHLM0042024-01-06
G503YHLM006YonhaYHLM0062024-01-06
G503YHLM009YonhaYHLM0092024-01-06
G503YHLM011YonhaYHLM0112024-01-06
G503YHLM013YonhaYHLM0132024-01-06
G503YHLM016YonhaYHLM0162024-01-06
G503YHLM017YonhaYHLM0172024-01-06
G503YHLM018YonhaYHLM0182024-01-06
G503YHLM019YonhaYHLM0192024-01-06
G503YHLM020YonhaYHLM0202024-01-06
G503YHLM021YonhaYHLM0212024-01-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
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00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
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00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16