FDA.report

MIRCOM PRODUCTS LLC

Primary DI
B866MKDT6501
Brand
MIRCOM PRODUCTS LLC
Company
ARMEDICA MANUFACTURING CORP.
Model
KDT650
Catalog number
KDT650
Device description
STEEL, 115V ELECTRIC, PEDESTAL MOUNTED, MULTI SECTION TREATMENT TABLE WITH POWERED ADJUSTABLE HEAD SECTION, ADJUSTABLE ARMRESTS, POWERED ADJUSTABLE TAIL SECTION WITH LUMBAR, ADJUSTABLE CENTER AND FOOT SECTIONS ON ROLLER TRACK, MACHINE STAND, AND CASTERS
Published
2022-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INQTable, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B866PKDT6501PackageHIBCC1In Commercial Distribution
B866MKDT6501PrimaryHIBCC0

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

Regulatory Flags

DUNS number
018941711
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B866PAMTM1001ARMEDICAAMTM100AMTM1002024-12-06
B866PAMTM12271ARMEDICAAMTM1227AMTM12272024-12-06
B866PAMTM1341ARMEDICAAMTM134AMTM1342024-12-06
B866PAMTM1401ARMEDICAAMTM140AMTM1402024-12-06
B866PAMTM1501ARMEDICAAMTM150AMTM1502024-12-06
B866PAMTM2001ARMEDICAAMTM200AMTM2002024-12-06
B866PAMTM227ARMEDICAAMTM227AMTM2272024-12-06
B866PAMTM2341ARMEDICAAMTM234AMTM2342024-12-06
B866PAMTM2401ARMEDICAAMTM240AMTM2402024-12-06
B866PAMTM2501ARMEDICAAMTM250AMTM2502024-12-06
B866PAMTM3001ARMEDICAAMTM300AMTM3002024-12-06
B866PAMTM334ARMEDICAAMTM334AMTM3342024-12-06
B866PAMTM3401ARMEDICAAMTM340AMTM3402024-12-06
B866PAMTM3501ARMEDICAAMTM350AMTM3502024-12-06
B866PAMTM3531ARMEDICAAMTM353AMTM3532024-12-06
B866PAMTM4001ARMEDICAAMTM400AMTM4002024-12-06
B866PAMTM4501ARMEDICAAMTM450AMTM4502024-12-06
B866PAMTM5001ARMEDICAAMTM500AMTM5002024-12-06
B866PAMTM5051ARMEDICAAMTM505AMTM5052024-12-06
B866PAMTM5501ARMEDICAAMTM550AMTM5502024-12-06

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B866PAMTM12271ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM1341ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM1401ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM1501ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM2001ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM227ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM2341ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06
B866PAMTM2401ARMEDICAARMEDICA MANUFACTURING CORP.INQ2024-12-06