FDA.reportPublic FDA data

ELMED

Primary DI
00198506002618
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST315501
Device description
"GOMCO STYLE CIRCUMCISION CLAMP, X - SMALL 1.1CM (7/16"") Autoclavable Medical Grade Stainless Steel."
Published
2024-04-24
Public version status
Update
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
00198506002618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506002618001985060026181985060026180198506002618

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
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
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
10198956127388CARDINAL HEALTHCardinal Health 200, LLCKOA2025-07-07
00190776399115MillenniumAvalign Technologies, Inc.KOA2025-05-27
04049047779162GimmiGimmi GmbHKOA2025-05-27
10198956045200CARDINAL HEALTHCardinal Health 200, LLCKOA2025-05-22
00198506083013ELMED INCORPORATEDELMED INCORPORATEDKOA2025-05-22
00198506074578ELMED INCORPORATEDELMED INCORPORATEDKOA2025-01-22
00840306829703Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829758Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829796Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829802Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829833Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829871Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829888Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829895Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
00840306829925Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-01-16
10649111492532Trinity Sterile, Inc.Trinity Sterile, Inc.HFB2024-12-16