FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506070525
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST321604E
Catalog number
ST321604E
Device description
LASER BLACK LATERAL WALL VAGINAL RETRACTOR, GOLD PLATED RATCHET HANDLE—OPEN SHANKS—10 1/12” OVERALL LENGTH, 4 1/2” X 1” BLADE SIZE
Published
2024-11-04
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
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506070525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506070525001985060705251985060705250198506070525

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
Premarket exempt
true
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
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
00190776400507MillenniumAvalign Technologies, Inc.HDL2026-07-19
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440096Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440102Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440119Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440126Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440133Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440164Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440324Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440331Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440348Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440355Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440362Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26