FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506064555
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST5501520A
Catalog number
ST5501520A
Device description
DEEP BASE, LID, INSERT TRAY & 2 MATS, 10.0 X 15.0 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
00198506064555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506064555001985060645551985060645550198506064555

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
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
10198956493612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956501973CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
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10198956530935CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956531925CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518902CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524934CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524965CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528772CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528819CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956529137CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956531888CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532519CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532892CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956380615CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956477384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956497887CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529175CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
00190446917861Arsenal FootTrilliant Surgical, LLCLRP2026-06-25