FDA.reportPublic FDA data

Yonha

Primary DI
G503YHLM011
Brand
Yonha
Company
Changzhou Yonghua Medical Instruments Co ., Ltd.
Model
YHLM011
Device description
2.0mm x 100mm Twist Drill, Quick Connect
Published
2024-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G503YHLM011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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
G503YHLM023YonhaYHLM0232024-01-06
G503YHLM007YonhaYHLM0072024-01-09
G503YHLM001YonhaYHLM0012024-01-06
G503YHLM002YonhaYHLM0022024-01-06
G503YHLM003YonhaYHLM0032024-01-06
G503YHLM004YonhaYHLM0042024-01-06
G503YHLM006YonhaYHLM0062024-01-06
G503YHLM009YonhaYHLM0092024-01-06
G503YHLM013YonhaYHLM0132024-01-06
G503YHLM016YonhaYHLM0162024-01-06
G503YHLM017YonhaYHLM0172024-01-06
G503YHLM018YonhaYHLM0182024-01-06
G503YHLM019YonhaYHLM0192024-01-06
G503YHLM020YonhaYHLM0202024-01-06
G503YHLM021YonhaYHLM0212024-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446960324DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960331DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960348DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960409DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960416DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00889024715271Affixus®Zimmer, Inc.HTW2026-10-06
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30