FDA.reportPublic FDA data

ELMED

Primary DI
00842180162488
Brand
ELMED
Company
ELMED INCORPORATED
Model
12-1022AK
Catalog number
12-1022AK
Device description
"Stainless Steel Mayo Instrument Tray, 15"" x 11"" x 3/4"""
Published
2023-03-16
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
00842180162488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180162488008421801624888421801624880842180162488

GMDN Terms#

Term, Definition table
TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

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
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190076MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190137MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190304MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190342MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190380MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190564MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191066MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191073MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191080MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191097MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191103MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191141MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191189MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190250MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16