FDA.reportPublic FDA data

My Medical

Primary DI
G425200509
Brand
My Medical
Company
My Medical Store LLC
Model
200-509
Catalog number
200-509
Device description
Bone Rongeur Curved 15 cm200-509
Published
2023-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G425200509PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116446487
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G4250010My MedicalCAL-001CAL-0012026-05-04
G4250020My MedicalCAL-002CAL-0022026-05-04
G425050183SCD0My Medical050-183SCD050-183SCD2026-05-04
G4250601180My Medical060-118060-1182026-05-04
G4250601350My Medical060-135060-1352026-05-04
G4250602970My Medical060-297050-2972026-05-04
G4250602980My Medical060-298060-2982026-05-04
G425110676LSI0My Medical110-676LSI110-676LSI2026-05-04
G425110686LSI0My Medical110-686LSI110-686LSI2026-05-04
G4251902480My Medical190-248190-2482026-05-04
G425310840NC0My Medical310-840NC310-840NC2026-05-04
G4254202900My Medical420-290420-2902026-05-04
G4254203160My Medical420-316420-3162026-05-04
G4254209120My Medical420-912420-9122026-05-04
G4254209140My Medical420-914420-9142026-05-04
G4254402140My Medical440-214440-2142026-05-04
G4254403120My Medical440-312440-3122026-05-04
G425050933SC0My Medical050-933SC050-933SC2026-03-27
G4255721131S0My Medical572-1131S572-1131S2026-02-27
G4250605120My Medical060-512060-5122026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13
B382SD9227021010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92270212C0Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707140Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707150Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707160Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707170Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707180Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707190Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734060Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734070Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734080Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738100Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381000Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381020Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738990Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92274510120Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227771090Surgical DirectSurgical Direct, Inc.HTX2026-07-10
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
08809695610370AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTX2025-03-17