FDA.reportPublic FDA data

Type-S™ Thermoplastic

Primary DI
00841439103142
Brand
Type-S™ Thermoplastic
Company
MEDTEC, INC.
Model
MTAPS2.4
Catalog number
MTAPS2.4
Device description
Reloadable 43.2cm standard thermoplastic (2.4mm)
Published
2019-04-01
Public version status
Update
Distribution status
Not 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
00841439103142PrimaryGS10
10841439103149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439103142008414391031428414391031420841439103142
1084143910314910841439103149

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
Storage Environment Temperature0100 Degrees Fahrenheit
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
103977526
Device count
5
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841439102374Uni-frame® BaseplateMT20100MT201002017-08-02
00841439102411Uni-frame® BaseplateMT20104MT201042017-08-02
00841439102428Uni-frame® BaseplateMT20108MT201082017-08-02
00841439104163Type-S™ Variable Axis BaseplateMTCFHNVAB01MTCFHNVAB012017-08-02
00841439107003Prone-Lok™ Positioning CushionMTPLC01MTPLC012017-08-02
00841439109939Type-S™ Overlay1080731080732017-08-02
00841439110621Posifix® Variable Axis Baseplate1070651070652017-08-02
00841439111956Vac-Lok™ CushionVLWGB03VLWGB032018-05-07
00841439111963Vac-Lok™ CushionVLPLV02VLPLV022018-05-07
00841439111970Vac-Lok™ CushionVLPLV01VLPLV012018-05-07
00841439111987Vac-Lok™ CushionVLJ20VLJ202018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22