FDA.reportPublic FDA data

Alloy Melter

Primary DI
00841439111369
Brand
Alloy Melter
Company
MEDTEC, INC.
Model
MT801.5DEX
Catalog number
MT801.5DEX
Device description
4 quart, 230V
Published
2018-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPYShield, protective, personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439111369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439111369008414391113698414391113690841439111369

GMDN Terms#

Term, Definition table
TermDefinition
Melting pot unitA mains electricity (AC-powered) device designed for the melting and pouring/tapping of materials in a safe and controlled manner, e.g., paraffin wax for use in the laboratory for embedding tissue samples, Rose's metal for the production of beam blocks in radiotherapy departments. It consists of a heating element that can be of varying designs, e.g., hollow thermal heater, flat plate heater, and a pot/pitcher that may pour through an open top or have a tap at the bottom for the tapping of clean material avoiding residue that may have risen to the surface.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14.87Inch
Width13.05Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(712)737-8688radiotherapy.complaints@civcort.com

Regulatory Flags#

DUNS number
103977526
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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00841439109793Fiducial MarkersMTNW887855MTNW8878552017-08-02
00841439103029AccuForm™ CushionMTACL14242MTACL142422017-08-02
00841439103036AccuForm™ CushionMTACL1520MTACL15202017-08-02
00841439103081AccuForm™ CushionMTACL6060MTACL60602017-08-02
00841439103098AccuForm™ CushionMTACLTYPES1MTACLTYPES12017-08-02
00841439107591Lok-Bar™MTSBRT264MTSBRT2642017-08-02
00841439115152Upright Arm PositionerRT-4900RT-49002026-01-08
00841439113059Registration FilmPRO340PRO3402019-10-10
00841439114032Pediatric Registration FilmPRO440PRO4402022-08-20
00841439113240Solstice™ MR SRS Immobilization SystemCHS04MRCHS04MR2020-07-10
00841439110904RediFoam™MTFA41BMTFA41B2017-08-02
00841439110911RediFoam™MTFA40BMTFA40B2017-08-02
00841439110928RediFoam™MTFA39BMTFA39B2017-08-02
00841439101056Low Kneefix™ 23010483010482017-08-02
00841439101070Kneefix™ 33010523010522017-08-02
00841439101124Feetfix™ 33010713010712017-08-02

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Primary DI, Brand, Company table
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00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
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