FDA.reportPublic FDA data

ELMED

Primary DI
00842180189522
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST10122401
Catalog number
ST10122401
Device description
PAD ONLY FOR LEG HOLDER 101-224, GRAY
Published
2024-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDCTable, Operating-Room, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180189522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180189522008421801895228421801895220842180189522

GMDN Terms#

Term, Definition table
TermDefinition
Leg procedure positionerA preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. 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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091896ELMED INCORPORATEDSTE12600STE126002026-07-22
00198506091902ELMED INCORPORATED37-1008137-100812026-07-22
00198506091919ELMED INCORPORATEDSTE3375906STE33759062026-07-22
00198506091926ELMED INCORPORATEDSTE241502STE2415022026-07-22
00198506091933ELMED INCORPORATED31740-2231740-222026-07-22
00198506091940ELMED INCORPORATED23-403223-40322026-07-22
00198506091957ELMED INCORPORATEDSTE5210201A4SSSTE5210201A4SS2026-07-22
00198506091964ELMED INCORPORATEDSTE321011IVSTE321011IV2026-07-22
00198506091971ELMED INCORPORATED37001-3637001-362026-07-22
00198506091988ELMED INCORPORATED24946-3424946-342026-07-22
00198506091995ELMED INCORPORATEDSTE3219400EVSTE3219400EV2026-07-22
00198506092008ELMED INCORPORATEDSTE3219401EVSTE3219401EV2026-07-22
00198506092015ELMED INCORPORATEDB9911 FAD-CB9911 FAD-C2026-07-22
00198506092053ELMED INCORPORATEDST233051ST2330512026-07-22
00198506092060ELMED INCORPORATEDST233052ST2330522026-07-22
00198506092077ELMED INCORPORATEDST233053ST2330532026-07-22
00198506092084ELMED INCORPORATEDST233054ST2330542026-07-22
00198506092091ELMED INCORPORATEDST233055ST2330552026-07-22
00198506092138ELMED INCORPORATEDST129927ST1299272026-07-22
00198506092848ELMED INCORPORATEDST5303078ST53030782026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260647945928Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2026-06-22
00728564070009Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00728564075004Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGGDC2025-01-17
00857534006721Headboard AssemblyIMRIS Imaging, Inc.GDC2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGGDC2023-01-17
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761968660Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967526TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27