FDA.reportPublic FDA data

My Medical

Primary DI
G4252005120
Brand
My Medical
Company
My Medical Store LLC
Model
200-512
Catalog number
200-512
Device description
Rhinoplasty Rasp, Curved
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
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4252005120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It is typically a one-piece instrument which resembles a coarse or fine file, but with sharp cutting projections instead of lines and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
08806395408917PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
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10381780280859Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
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10381780467076Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
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10381780192862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780193012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780461616Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-22
10381780212188Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01
10381780212195Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01