FDA.reportPublic FDA data

ELMED

Primary DI
00842180190603
Brand
ELMED
Company
ELMED INCORPORATED
Model
32-26-32
Catalog number
32-26-32
Device description
HEGAR DILATORS SIZE 31/32
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00842180190603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180190603008421801906038421801906030842180190603

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
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
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586NSGU40600160Novo SurgicalNOVO SURGICAL, INC.HDQ2024-03-08
GYNX42111GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42121GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42221GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42231GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42401GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42451GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42501GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42551GynexGYNEX CORPORATIONHDQ2023-12-19
08800142923982V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924019V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924040V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924071V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924101V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924132V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
07898506815050QuinelatoSchobell Industrial LtdaHDQ2023-01-09
07899798202634SchobellSchobell Industrial LtdaHDQ2023-01-09
10653160351276CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160351283CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160351290CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-03-28
10653160314332CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-01-01
10381780509363Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780509370Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780500728Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500735Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500742Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500759Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500766Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18