FDA.reportPublic FDA data

Hawkin Ambler Dilator

Primary DI
M803030787
Brand
Hawkin Ambler Dilator
Company
MEDGYN PRODUCTS, INC.
Model
Hawkin Ambler Dilator 9-12 mm
Catalog number
030787
Device description
Hawkin Ambler Dilator 9-12 mm
Published
2025-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
M803030787PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103913430
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
M803010466MedGyn Video ColposcopeAL-106HD010466HD2016-09-08
M803003276512Uterine ManipulatorUterine Manipulator/ InjectorTMI11512026-06-08
M803003276515Uterine ManipulatorUterine Manipulator/ InjectorTMI11512026-06-08
M8030030134Baby Tischler Biopsy Punch Titanium"Baby Tischler Biopsy Punch Titanium 10"" (254mm) 0301342025-11-16
M8030030139Tischler Biopsy Punch Titanium"Tischler Biopsy Punch Titanium 8 1/2"" (216mm) - 0301392025-11-16
M803029801Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Up"0298012025-11-16
M803029802Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Down"0298022025-11-16
M803029803Tischler Biopsy Punch"Tischler Biopsy Punch 10"" (254mm) Left"0298032025-11-16
M803029804Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Right"0298042025-11-16
M803029811Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Up "0298112025-11-16
M803029812Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Down"0298122025-11-16
M803029813Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10"" (254mm) Left"0298132025-11-16
M803029814Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Right"0298142025-11-16
M803030101Tischler Biopsy Punch"Tischler Biopsy Punch 81/2"" (216mm)"0301012025-11-16
M80303010110"Tischler Biopsy Punch 10"" (254mm)""Tischler Biopsy Punch 10"" (254mm)"030101102025-11-16
M803030102Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 81/2"" (216mm)"0301022025-11-16
M80303010210Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10""(254mm)"030102102025-11-16
M803030103Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 81/2"" (216mm)"0301032025-11-16
M80303010310Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 10"" (254mm)"030103102025-11-16
M803030104Rotating Tischler Biopsy PunchRotating Tischler Biopsy Punch0301042025-11-16

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Primary DI, Brand, Company table
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00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
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