FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506092367
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST2110225
Catalog number
ST2110225
Device description
probe buttoned with eye D 2mm, 25cm
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506092367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506092367001985060923671985060923670198506092367

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506039072ELMED INCORPORATEDST5240905ST52409052026-07-17
00198506092107ELMED INCORPORATEDST233061ST2330612026-07-17
00198506092114ELMED INCORPORATEDST233064ST2330642026-07-17
00198506092121ELMED INCORPORATEDST233065ST2330652026-07-17
00198506092152ELMED INCORPORATEDST1976718ST19767182026-07-17
00198506092176ELMED INCORPORATEDST5220340ST52203402026-07-17
00198506092190ELMED INCORPORATEDST5243000HST5243000H2026-07-17
00198506092206ELMED INCORPORATEDST5243004HST5243004H2026-07-17
00198506092213ELMED INCORPORATEDST5243005HST5243005H2026-07-17
00198506092220ELMED INCORPORATEDST5246000HST5246000H2026-07-17
00198506092237ELMED INCORPORATEDST5246003HST5246003H2026-07-17
00198506092244ELMED INCORPORATEDST5246004HST5246004H2026-07-17
00198506092251ELMED INCORPORATEDST5246005HST5246005H2026-07-17
00198506092268ELMED INCORPORATEDST5246006HST5246006H2026-07-17
00198506092275ELMED INCORPORATEDST5240900ST52409002026-07-17
00198506092282ELMED INCORPORATEDST5240901ST52409012026-07-17
00198506092299ELMED INCORPORATEDST5240904ST52409042026-07-17
00198506092305ELMED INCORPORATEDST5241200ST52412002026-07-17
00198506092312ELMED INCORPORATEDST5241201ST52412012026-07-17
00198506092329ELMED INCORPORATEDST5241202ST52412022026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400477MillenniumAvalign Technologies, Inc.MDM2026-07-17
00198506092374ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
00198506092381ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29