FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506091582
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
13579-21
Catalog number
13579-21
Device description
Hysterectomy Forceps, Wertheim-Cullen, 8" (21.5cm)
Published
2026-06-10
Public version status
New
Distribution status
Not 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
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506091582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506091582001985060915821985060915820198506091582

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, reusableA collection of various surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical procedure; it does not contain pharmaceuticals. 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
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437718MilleniumAvalign Technologies, Inc.HFB2026-10-20
00190776423834MillenniumAvalign Technologies, Inc.HFB2026-08-26
00190776425845MillenniumAvalign Technologies, Inc.HFB2026-08-17
00190776411503MillenniumAvalign Technologies, Inc.HFB2026-08-07
00198506093630ELMED INCORPORATEDELMED INCORPORATEDHFB2026-07-29
06975339628406Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628413Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628598Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628604Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628611Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628628Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
00190776421779MillenniumAvalign Technologies, Inc.HFB2026-06-24
05060212052094Tischler Cervical Biopsy PunchDTR MEDICAL LIMITEDHFB2026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchDTR MEDICAL LIMITEDHFB2026-06-10
05060411987425Cervical Rotating Biopsy Punch SAMPLE SETDTR MEDICAL LIMITEDHFB2026-06-10
06950190431006NAZhuji Pengtian Medical Instrument Co.,Ltd.HFB2026-03-31
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
06973672291066JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
16973672291063JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
00194613029302MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613033590MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613060480MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613106423MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613108076MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117641MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117726MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01