FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506064784
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST5506511A
Catalog number
ST5506511A
Device description
BASE & LID 2.6 X 16.0 X 1.5
Published
2024-10-22
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506064784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506064784001985060647841985060647840198506064784

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09
00198506082801ELMED INCORPORATEDSTT9932FSANSTT9932FSAN2025-05-13
00198506056628ELMEDST9932FSANTSTT9932FSANT2024-07-29
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M697X07300271Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
10198956603554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956612822CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956618688CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956578487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956580961CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956591578CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956595576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604506CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605732CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605848CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605855CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
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10198956607668CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608900CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608924CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608931CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608948CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608955CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956609341CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956610651CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
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