FDA.reportPublic FDA data

ELMED

Primary DI
00198506000072
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST321013IV
Catalog number
ST321013IV
Device description
INSULATED WEISMAN GRAVES VAGINAL SPECULUM RIGHT STYLE A RIGHT SIDE OPEN LARGE BLADE 4-3/4 X 1-1/2" PERMANET SMOKE EVACUATION TUBE
Published
2024-04-24
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
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506000072001985060000721985060000720198506000072

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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
00190776418274MillenniumAvalign Technologies, Inc.HDF2026-03-23
B356JB543320American MedicalsAmerican MedicalsHDF2026-02-26
00198506088810ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-25
00198506088773ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00198506088780ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00190776416164MillenniumAvalign Technologies, Inc.HDF2026-02-06
00190776416171MillenniumAvalign Technologies, Inc.HDF2026-02-06
B356JB641170American MedicalsAmerican MedicalsHDF2026-02-06
00190776415594MillenniumAvalign Technologies, Inc.HDF2026-01-28
00190776415259MillenniumAvalign Technologies, Inc.HDF2026-01-27
00190776415266MillenniumAvalign Technologies, Inc.HDF2026-01-27
00198506088278ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-27
00198506087752ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087769ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087202ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-18
00198506087066ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-17
00190776415136MillenniumAvalign Technologies, Inc.HDF2025-12-03
00810158218062PRINCETONPrinceton Medical Group, Inc.HDF2025-11-17
M803030915Kogan 2-4mm w/screwMEDGYN PRODUCTS, INC.HDF2025-11-16
00198506067815ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506067822ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506068324ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00190776410650MillenniumAvalign Technologies, Inc.HDF2025-09-11
00198506085161ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-05
00190776409258MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776409289MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776408589MillenniumAvalign Technologies, Inc.HDF2025-08-19
00190776407995MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408008MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408077MillenniumAvalign Technologies, Inc.HDF2025-08-06