FDA.reportPublic FDA data

ELMED

Primary DI
00198506002670
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST315506
Catalog number
ST315506
Device description
"GOMCO STYLE CIRCUMCISION CLAMP, ADULT, 2.6CM (1"") 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
00198506002670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506002670001985060026701985060026700198506002670

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
00198506044366ELMEDST52732404EST52732404E2026-06-09
00198506091278ELMED INCORPORATED55013-10A55013-10A2026-06-09
00198506091285ELMED INCORPORATED12-53785-042T12-53785-042T2026-06-09
00198506091292ELMED INCORPORATEDSS22-5200-09ASS22-5200-09A2026-06-09
00198506091308ELMED INCORPORATEDSS22-5200-09FSS22-5200-09F2026-06-09
00198506091315ELMED INCORPORATEDSTE379670STE3796702026-06-09
00198506091322ELMED INCORPORATEDSTE379675STE3796752026-06-09
00198506091339ELMED INCORPORATEDSTESM150526JC08ISTESM150526JC08I2026-06-09
00198506091346ELMED INCORPORATEDSTE4570910STE45709102026-06-09
00198506091353ELMED INCORPORATEDSTE239935STE2399352026-06-09
00198506091360ELMED INCORPORATED37350-64C137350-64C12026-06-09
00198506091377ELMED INCORPORATEDS37520-64C1S37520-64C12026-06-09
00198506091384ELMED INCORPORATED37520-06C137520-06C12026-06-09
00198506091391ELMED INCORPORATEDS37520-06C1S37520-06C12026-06-09
00198506091407ELMED INCORPORATEDSTE122857STE1228572026-06-09
00198506091476ELMED INCORPORATED12-36-1812-36-182026-06-09
00198506091483ELMED INCORPORATED51-4080-0851-4080-082026-06-09
00198506091490ELMED INCORPORATEDSTE321202EVSTE321202EV2026-06-09
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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