FDA.report

ELMED INCORPORATED

Primary DI
00198506068898
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST322316IM
Catalog number
ST322316IM
Device description
INSULATED COMPACT WEIGHTED “E” VAGINAL SPECULUM, 2 1/2” LBS, 3 3/4” X 1 1/2” BLADE SIZE, 11" OVERALL LENGTH, WITH SLOTTED SMOKE TUBE FOR DISPOSABLE EVACUATION TUBE
Published
2024-11-13
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

Related Records

Contact Domains

Product Codes

CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications

CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00198506068898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506068898001985060688981985060688980198506068898

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
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
00198506089695ELMED INCORPORATEDSM-T9931FS-AN-TSM-T9931FS-AN-T2026-03-20
00198506089701ELMED INCORPORATEDSTE5502610ASTE5502610A2026-03-20
00198506089718ELMED INCORPORATEDSTE235920STE2359202026-03-20
00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
00198506089602ELMED INCORPORATED11126-1111126-112026-03-17
00198506089619ELMED INCORPORATEDSTE3610810600STE36108106002026-03-17
00198506089626ELMED INCORPORATED23-31-040223-31-04022026-03-17
00198506089633ELMED INCORPORATED40-652540-65252026-03-17
00198506089640ELMED INCORPORATED30670-2830670-282026-03-17
00198506089657ELMED INCORPORATED42-170042-17002026-03-17
00198506089664ELMED INCORPORATED38-1093-I38-1093-I2026-03-17
00198506089671ELMED INCORPORATED69127-0369127-032026-03-17
00198506089688ELMED INCORPORATED69127-0269127-022026-03-17
00198506089510ELMED INCORPORATEDSTE11510929STE115109292026-03-13

Other Devices Sharing Product Codes

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