FDA.reportPublic FDA data

Registration Film

Primary DI
00841439113059
Brand
Registration Film
Company
MEDTEC, INC.
Model
PRO340
Catalog number
PRO340
Device description
Registration Film
Published
2019-10-10
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180021000Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap2018-06-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841439113056PackageGS15In Commercial Distribution
00841439113059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084143911305610841439113056
00841439113059008414391130598414391130590841439113059

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning foam mould kitA collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould of that anatomy. The mould can be whole body or only selected body parts and are commonly used to help ensure adequate positioning and immobilization of the patient during radiation therapy treatments and to facilitate reproducible positioning for serial treatments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Single patient multiple use.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841439114732PronumbraRT-C876KRT-C876K2025-09-12
10841439114749PronumbraRT-C878KRT-C878K2025-09-12
10841439114770PronumbraRT-C889KRT-C889K2025-09-12
10841439114787PronumbraRT-C892KRT-C892K2025-09-12
00841439115114BioXmark112105902025-07-01
00841439109571Marker Placement NeedleMTNW887351MTNW8873512017-08-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21