FDA.reportPublic FDA data

Waterbath

Primary DI
00841439111338
Brand
Waterbath
Company
MEDTEC, INC.
Model
MTRH1500
Catalog number
MTRH1500
Device description
120V
Published
2018-06-14
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
IYEAccelerator, linear, medical
KPYShield, protective, personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
KPYShield, Protective, PersonnelRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933227000UNI-FRAME HEAD IMMOBILIZATION SYSTEMMedtec, Inc.1994-07-18IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439111338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439111338008414391113388414391113380841439111338

GMDN Terms#

Term, Definition table
TermDefinition
Thermoplastic-moulding water bathA mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a large water holder (pan) that is temperature-regulated from, e.g., room temperature to 100? Celsius, temperature controls, thermometer/thermostats, timer. Sheets or pre-cut pieces of thermoplastic materials are placed into the water with the temperature set according to the material specifications so that these become soft enough to mould to the required shape.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33.125Inch
Width28.5Inch

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

Other Devices From This Company#

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00841439109588Marker Placement NeedleMTNW887358MTNW8873582017-08-02
00841439109595Coupled™ Fiducial Marker KitMTNW887709MTNW8877092017-08-02
00841439109601Coupled™ Fiducial Marker KitMTNW887710MTNW8877102017-08-02
00841439109618Coupled™ Fiducial Marker KitMTNW887711MTNW8877112017-08-02
00841439109625Coupled™ Fiducial Marker KitMTNW887712MTNW8877122017-08-02
00841439109632Fiducial MarkersMTNW887805MTNW8878052017-08-02
00841439109649Fiducial MarkersMTNW887808MTNW8878082017-08-02
00841439109656Fiducial MarkersMTNW887809MTNW8878092017-08-02
00841439109663Fiducial Marker KitMTNW887810MTNW8878102017-08-02
00841439109670Fiducial MarkersMTNW887812MTNW8878122017-08-02
00841439109687Fiducial MarkersMTNW887814MTNW8878142017-08-02
00841439109694Fiducial Marker KitMTNW887825MTNW8878252017-08-02
00841439109700Fiducial Marker KitMTNW887830MTNW8878302017-08-02
00841439109717Fiducial Marker KitMTNW887835MTNW8878352017-08-02
00841439109724Fiducial Marker KitMTNW887836MTNW8878362017-08-02
00841439109731Fiducial Marker KitMTNW887837MTNW8878372017-08-02
00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02

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