FDA.reportPublic FDA data

Shoulder Strap Extender

Primary DI
10841439112844
Brand
Shoulder Strap Extender
Company
MEDTEC, INC.
Model
CRTSHLDEXT01
Catalog number
CRTSHLDEXT01
Device description
Shoulder Strap Extender
Published
2019-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K121284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121284000CHABNER XRT GARMENTSChabner Xrt, LLC2013-06-14IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841439112844PackageGS110In Commercial Distribution
00841439112847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084143911284410841439112844
00841439112847008414391128478414391128470841439112847

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner, wearableA garment designed to be worn by a female patient to support/position the breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is typically in the form of a brassiere.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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