FDA.reportPublic FDA data

ELMED

Primary DI
00842180156807
Brand
ELMED
Company
ELMED INCORPORATED
Model
31-55-00
Catalog number
31-55-00
Device description
"""GOMCO"" STYLE CIRCUMCISION CLAMP-INFANT X SMALL, 0.8CM (5/16"") AUTOCLAVABLE MEDICAL GRADE STAINLESS STEEL"
Published
2023-01-09
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
00842180156807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180156807008421801568078421801568070842180156807

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
00198506091667ELMED INCORPORATED32-509-04-I32-509-04-I2026-07-10
00198506091759ELMED INCORPORATED31430-00B31430-00B2026-07-10
00198506091803ELMED INCORPORATEDSTE3220413IVSTE3220413IV2026-07-10
00198506091810ELMED INCORPORATED31960-3131960-312026-07-10
00198506091827ELMED INCORPORATEDSTE321211AISTE321211AI2026-07-10
00198506091834ELMED INCORPORATEDSTE321212AISTE321212AI2026-07-10
00198506091841ELMED INCORPORATED31960-3631960-362026-07-10
00198506091858ELMED INCORPORATED31960-6331960-632026-07-10
00198506091865ELMED INCORPORATED20-2771820-277182026-07-10
00198506091872ELMED INCORPORATED9839FS9839FS2026-07-10
00198506091889ELMED INCORPORATED31560-2131560-212026-07-10
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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