FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506092343
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST5501380M
Catalog number
ST5501380M
Device description
SILICONE MAT (PERFORATED)
Published
2026-07-29
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
LRPTray, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506092343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506092343001985060923431985060923430198506092343

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
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
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956210240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956310933CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956480322CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956538337CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956546431CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956564503CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956572713CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956573963CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956575622CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956576575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956577404CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578166CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578364CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578739CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578876CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580046CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580060CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580237CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581258CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583573CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583641CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956520790CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956521001CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956568228CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569348CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26