FDA.reportPublic FDA data

Mevion Rectangular Backrest

Primary DI
00841439114513
Brand
Mevion Rectangular Backrest
Company
MEDTEC, INC.
Model
MTIL7111
Catalog number
MTIL7111
Device description
For use with Mevion S250-FIT Proton Therapy System™
Published
2024-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXQTable, radiographic, stationary top
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2
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
00841439114513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439114513008414391145138414391145130841439114513

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.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
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