FDA.reportPublic FDA data

Protura

Primary DI
00841439101971
Brand
Protura
Company
MEDTEC, INC.
Model
206X140
Catalog number
206X140
Device description
Protura, Kit, Elekta Precise
Published
2017-08-02
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
JAICouch, radiation therapy, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132084000PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions2013-09-26JAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439101971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439101971008414391019718414391019710841439101971

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841439109724Fiducial Marker KitMTNW887836MTNW8878362017-08-02
00841439109731Fiducial Marker KitMTNW887837MTNW8878372017-08-02
00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02

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10841962119457Symphony Locating Bar, Prodigy2™QfixJAI2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAI2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.JAI2025-09-12
00841962120340Edge Guide SystemQfixJAI2025-09-11
00841962119481Symphony™QfixJAI2025-07-09
00841962119498AirDrive Trolley™QfixJAI2025-07-09
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119528AirShuttle Locating BarQfixJAI2025-07-09
00841962119535AirShuttle Locating BarQfixJAI2025-07-09
00841962119542AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119559InfinityLock™QfixJAI2025-07-09
00841962119573AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119580InfinityLock™QfixJAI2025-07-09
00841962119597AltaQfixJAI2025-07-09
00841962119603AltaQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119689Stradivarius™QfixJAI2025-07-09
00841962119696Encompass™QfixJAI2025-07-09
00841962119702Encompass™QfixJAI2025-07-09
00841962119719Encompass™QfixJAI2025-07-09
00841962119726AltaQfixJAI2025-07-09