FDA.reportPublic FDA data

My Medical

Primary DI
G4251103020
Brand
My Medical
Company
My Medical Store LLC
Model
110-302
Catalog number
110-302
Device description
Saldanha Retractor
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4251103020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
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B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
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B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
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B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685612550Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-07-23
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13
B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7683359530Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30