FDA.reportPublic FDA data

Capre M4

Primary DI
06430021930460
Brand
Capre M4
Company
Lojer Oy
Model
Capre M4
Catalog number
Capre M4
Device description
Treatment table
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430021930460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430021930460064300219304606430021930460

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Transport temperature - 10 to +40 °C
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358108306700info@lojer.com

Regulatory Flags#

DUNS number
368184922
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430021930453Capre M2Capre M2Capre M22022-11-30
06430021930477Capre M4 AMCapre M4 AMCapre M4 AM2022-11-30
06430021930507Capre F2Capre F2Capre F22022-11-30
06430021930514Capre F3Capre F3Capre F32022-11-30
06430021930521Capre F5Capre F5Capre F52022-11-30
06430021930538Capre F5 AMCapre F5 AMCapre F5 AM2022-11-30
06430021930569Capre FX3Capre FX3Capre FX32022-11-30
06430021930576Capre FX5Capre FX5Capre FX52022-11-30
06430021930668Manuthera 242Manuthera 242Manuthera 2422022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00815235022679UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022686UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
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00815235022839UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022846UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022853UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
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