FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506083013
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST31550201
Catalog number
ST31550201
Device description
GOMCO CLAMP STUD BELL, 1.3CM
Published
2025-05-22
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
HFBForceps, Biopsy, Gynecological
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506083013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506083013001985060830131985060830130198506083013

GMDN Terms#

Term, Definition table
TermDefinition
Circumcision kit, reusableA collection of various instruments, dressings, and possibly pharmaceuticals used to perform a circumcision procedure. Typical components include disinfectant, circumcision clamp, scissors, and scalpel. 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
00198506092183ELMED INCORPORATEDST5352077ST53520772026-07-29
00198506092343ELMED INCORPORATEDST5501380MST5501380M2026-07-29
00198506092350ELMED INCORPORATEDST3510800800ST35108008002026-07-29
00198506092640ELMED INCORPORATEDSTST5250541STST52505412026-07-29
00198506093197ELMED INCORPORATEDST7511814ST75118142026-07-29
00198506093487ELMED INCORPORATEDST233985ST2339852026-07-29
00198506093494ELMED INCORPORATEDST231006TST231006T2026-07-29
00198506093500ELMED INCORPORATEDST234215SSST234215SS2026-07-29
00198506093517ELMED INCORPORATEDST235066ST2350662026-07-29
00198506093524ELMED INCORPORATEDST231875DST231875D2026-07-29
00198506093531ELMED INCORPORATEDST234558ST2345582026-07-29
00198506093548ELMED INCORPORATEDST235930ST2359302026-07-29
00198506093555ELMED INCORPORATEDST23742503ST237425032026-07-29
00198506093562ELMED INCORPORATEDST5250223ST52502232026-07-29
00198506093579ELMED INCORPORATEDSTF9932 FSTF9932 F2026-07-29
00198506093586ELMED INCORPORATEDST1109400ST11094002026-07-29
00198506093593ELMED INCORPORATEDST420958ST4209582026-07-29
00198506093609ELMED INCORPORATEDST3315705ST33157052026-07-29
00198506093616ELMED INCORPORATEDST3380118ST33801182026-07-29
00198506093630ELMED INCORPORATEDST3155NUTST3155NUT2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD500500Surgical DirectSurgical Direct, Inc.KOA2026-08-03
00198506093630ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-29
00198506093630ELMED INCORPORATEDELMED INCORPORATEDHFB2026-07-29
00198506092169ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-27
00198506091933ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093128ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093135ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506091759ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091810ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091841ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091858ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091889ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
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
00198506091582ELMED INCORPORATEDELMED INCORPORATEDHFB2026-06-10
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
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24