FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506018268
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST5200513W
Catalog number
ST5200513W
Device description
BLUE SEALING CAP FOR KLEPPINGER SCISSORS STYLE BIPOLAR FORCEPS (10/PKG)
Published
2025-09-05
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
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506018268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506018268001985060182681985060182680198506018268

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, reusableA collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
true
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
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
09421028490412PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490429PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490436PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490443PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490535PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490153PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490566PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490580PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490764PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493079PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493116PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490399PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-24
09421028490320PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028493154PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028490221PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028490788PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10