FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506093708
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST7141021
Catalog number
ST7141021
Device description
Single Ended Hegar Dilator, 21mm Tip, Autoclavable Medical Grade Stainless Steel
Published
2026-07-22
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
00198506093708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506093708001985060937081985060937080198506093708

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
00198506091896ELMED INCORPORATEDSTE12600STE126002026-07-22
00198506091902ELMED INCORPORATED37-1008137-100812026-07-22
00198506091919ELMED INCORPORATEDSTE3375906STE33759062026-07-22
00198506091926ELMED INCORPORATEDSTE241502STE2415022026-07-22
00198506091933ELMED INCORPORATED31740-2231740-222026-07-22
00198506091940ELMED INCORPORATED23-403223-40322026-07-22
00198506091957ELMED INCORPORATEDSTE5210201A4SSSTE5210201A4SS2026-07-22
00198506091964ELMED INCORPORATEDSTE321011IVSTE321011IV2026-07-22
00198506091971ELMED INCORPORATED37001-3637001-362026-07-22
00198506091988ELMED INCORPORATED24946-3424946-342026-07-22
00198506091995ELMED INCORPORATEDSTE3219400EVSTE3219400EV2026-07-22
00198506092008ELMED INCORPORATEDSTE3219401EVSTE3219401EV2026-07-22
00198506092015ELMED INCORPORATEDB9911 FAD-CB9911 FAD-C2026-07-22
00198506092053ELMED INCORPORATEDST233051ST2330512026-07-22
00198506092060ELMED INCORPORATEDST233052ST2330522026-07-22
00198506092077ELMED INCORPORATEDST233053ST2330532026-07-22
00198506092084ELMED INCORPORATEDST233054ST2330542026-07-22
00198506092091ELMED INCORPORATEDST233055ST2330552026-07-22
00198506092138ELMED INCORPORATEDST129927ST1299272026-07-22
00198506092848ELMED INCORPORATEDST5303078ST53030782026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
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00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
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GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42221GynexGYNEX CORPORATIONHDQ2023-12-19