FDA.reportPublic FDA data

ELMED

Primary DI
00842180186026
Brand
ELMED
Company
ELMED INCORPORATED
Model
32-26-28
Catalog number
32-26-28
Device description
HEGAR DILATOR 27/28
Published
2024-02-20
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
HDXDilator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180186026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180186026008421801860268421801860260842180186026

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

Contacts#

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

Regulatory Flags#

DUNS number
049290364
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
true
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
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
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432243Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432250Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432267Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432274Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432281Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432298Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432304Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432205Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
04719894432212Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
04719894432229Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
00842180184909ELMEDELMED INCORPORATEDHDX2024-01-18
00842180184275ELMEDELMED INCORPORATEDHDX2024-01-05
00842180183421ELMEDELMED INCORPORATEDHDX2023-12-11
00842180183438ELMEDELMED INCORPORATEDHDX2023-12-11
00842180183445ELMEDELMED INCORPORATEDHDX2023-12-11
00842180183452ELMEDELMED INCORPORATEDHDX2023-12-11