FDA.reportPublic FDA data

My Medical

Primary DI
G4252602000
Brand
My Medical
Company
My Medical Store LLC
Model
260-200
Catalog number
260-200
Device description
Hank Dilator Set
Published
2023-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4252602000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. 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

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Primary DI, Brand, Company table
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