FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319748053
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
290-150-17
Catalog number
290-150-17
Device description
Hegar S/E Dilators - (Set of 17) 1.0mm - 9.0mm, includes .5mm sizes
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00840319748053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319748053008403197480538403197480530840319748053

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

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319723944Hayden Medical300-007300-0072022-08-16
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417789MillenniumAvalign Technologies, Inc.HDQ2026-03-11
00198506088230ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088247ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088254ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088261ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506087981ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088018ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088025ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088032ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088049ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
04262494463143N/ADoppkon GmbH & Co. KGHDQ2025-12-04
04262494462986N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494462993N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463006N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463013N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463020N/ADoppkon GmbH & Co. KGHDQ2025-12-01
00190776411671MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411688MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411695MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411732MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411749MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411756MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411459MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411466MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411596MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411602MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411435MillenniumAvalign Technologies, Inc.HDQ2025-09-22
00190776411442MillenniumAvalign Technologies, Inc.HDQ2025-09-22