FDA.reportPublic FDA data

Prone-Lok™ Positioning Cushion

Primary DI
00841439107003
Brand
Prone-Lok™ Positioning Cushion
Company
MEDTEC, INC.
Model
MTPLC01
Catalog number
MTPLC01
Device description
(40.6 x 40.6cm)
Published
2017-08-02
Public version status
Update
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973842000CARBON FIBER CONFORMAL COUCH TOPMedtec, Inc.1997-12-05IXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439107003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439107003008414391070038414391070030841439107003

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep away from sunlight.

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
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
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
00841439111994Vac-Lok™ CushionVLG40VLG402018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115213Alta Indexing BarMEDTEC, INC.IXQ2026-05-06
00841439115152Upright Arm Positioner MEDTEC, INC.IXQ2026-01-08
00841439115145PronumbraMEDTEC, INC.IXQ2025-10-23
00841439114650PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114674PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114681PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114698PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114704PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114711PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114728PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114995PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115008PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115084ONEFitMEDTEC, INC.IXQ2025-09-12
00841439115121PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115138PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114732PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114749PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114770PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114787PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115015Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
00841439115022Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
00841439115039Posi Indexing BarMEDTEC, INC.IXQ2025-01-02
00841439114766Universal Couchtop™MEDTEC, INC.IXQ2024-10-18
00841439114759Rectangular ExtensionMEDTEC, INC.IXQ2024-10-01
B237OGSAPH100Diacor CT OverlayDiacor, Inc.IXQ2024-07-11
00841439114599Pro Posifix® Headrest AdapterMEDTEC, INC.IXQ2024-05-16
00841439114513Mevion Rectangular BackrestMEDTEC, INC.IXQ2024-02-03
00841439114544Universal Couchtop™MEDTEC, INC.IXQ2024-01-22
00841439114551Universal Couchtop™MEDTEC, INC.IXQ2024-01-22
00817463027174Oakworks MedicalOAKWORKS, INC.IXQ2023-12-06