FDA.reportPublic FDA data

Prone Shell

Primary DI
00841439102473
Brand
Prone Shell
Company
MEDTEC, INC.
Model
MT20215
Catalog number
MT20215
Device description
Reusable non-sterile Vac-Lok™ interface with extension hose
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
IWYHolder, head, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439102473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439102473008414391024738414391024730841439102473

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length26.4Centimeter
Width14Centimeter

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439115152Upright Arm PositionerRT-4900RT-49002026-01-08
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
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00810050245487NADOMICO MED-DEVICE, LLCIWY2023-05-01
G242RHIAB9Techno-AideTechno-Aide, Inc.IWY2023-02-13
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.IWY2023-01-25
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00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
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