FDA.report

ELMED

Primary DI
00842180174559
Brand
ELMED
Company
ELMED INCORPORATED
Model
115 515/715-99
Catalog number
115 515/715-99
Device description
COMPLETE CABLE ASSEMBLY WITH PLUG FOR FOOTSWITCH ON TABLE 115 5150/715
Published
2023-07-28
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

Related Records

Contact Domains

Product Codes

CodeName
FRKChair, Examination And Treatment

Product Code Classifications

CodeDeviceSpecialtyClass
FRKChair, Examination And TreatmentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180174559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180174559008421801745598421801745590842180174559

GMDN Terms

TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
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00198506089756ELMED INCORPORATED42-191042-19102026-03-23

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