FDA.reportPublic FDA data

GE MR Posifix® Baseplate

Primary DI
00841439114667
Brand
GE MR Posifix® Baseplate
Company
MEDTEC, INC.
Model
101027
Catalog number
101027
Device description
Acrylic Baseplate
Published
2024-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093738000MRI PATIENT POSITIONING DEVICESMedtec, Inc.2010-05-14LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439114667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439114667008414391146678414391146670841439114667

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.

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
00841439114391AccuForm™ CushionMTACLTYPESNMTACLTYPESN2023-03-11
00841439113844Vac-Lok™ CushionVLPLV10CVLPLV10C2022-03-24
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02
00841439109779Fiducial Marker KitMTNW887853MTNW8878532017-08-02
00841439109793Fiducial MarkersMTNW887855MTNW8878552017-08-02
00841439103029AccuForm™ CushionMTACL14242MTACL142422017-08-02
00841439103036AccuForm™ CushionMTACL1520MTACL15202017-08-02
00841439103081AccuForm™ CushionMTACL6060MTACL60602017-08-02
00841439103098AccuForm™ CushionMTACLTYPES1MTACLTYPES12017-08-02
00841439107591Lok-Bar™MTSBRT264MTSBRT2642017-08-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396022676WGS-100 Respiration PillowIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023550WGS-100 Wireless Gating SystemIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023567WGS-100 TransmitterIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023574WGS-100 Base StationIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
07090042059091nordicAktivaNordicneurolab ASLNH2026-08-03
00866463000496STAGESpintech, Inc.LNH2026-07-23
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12