FDA.reportPublic FDA data

HipFix® Thermoplastic

Primary DI
10841439104306
Brand
HipFix® Thermoplastic
Company
MEDTEC, INC.
Model
MTHFX18222.4
Catalog number
MTHFX18222.4
Device description
45.7 x 55.9cm standard perforated thermoplastic (2.4mm)
Published
2017-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080072000
K093738000
K933227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080072000MRI PATIENT POSITIONING DEVICESCIVCO Medical Instruments Co., Inc.2008-06-04IYE
K093738000MRI PATIENT POSITIONING DEVICESMedtec, Inc.2010-05-14LNH
K933227000UNI-FRAME HEAD IMMOBILIZATION SYSTEMMedtec, Inc.1994-07-18IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439104309PackageGS15In Commercial Distribution
10841439104306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439104309008414391043098414391043090841439104309
1084143910430610841439104306

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Single patient multiple use.
Storage Environment Temperature0100 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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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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