FDA.reportPublic FDA data

CastWedge™

Primary DI
G064208317270092501
Brand
CastWedge™
Company
POSITION HEALTH, LLC
Model
20831727009250
Catalog number
20831727009250
Device description
(25 mm) CastWedge™ Cast Adjuster. Designed for cast realignment and swelling relief. Use with plaster or fiberglass cast.
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGFComponent, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGFComponent, CastOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G064208317270092501PrimaryHIBCC0
G064208317270092500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cast spreader, single-useA hand-operated device intended to be used to adjust a plaster cast around a patient's limb or body part, typically for relief of post-operative swelling. It is in the form of a wedge with edges which is slid along the cast to maintain a precise opening and make exact adjustments to the cast. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-254-5438info@positionhealthusa.com

Regulatory Flags#

DUNS number
116685742
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0648317270013971TurnAssist®8317270013978317270013972022-12-09
G064108317270090000ELBOWLIFT®10831727009000108317270090002022-12-09
G064108317270093210HEELIFT® TRACTION10831727009321108317270093212022-12-09
G064208317270091511CastWedge™20831727009151208317270091512022-12-09
G064208317270092051CastWedge™20831727009205208317270092052022-12-09
G064208317270093041CastWedge™20831727009304208317270093042022-12-09
G064208317270097860HEELIFT® 20831727009786208317270097862022-12-09
G0648317270013731TurnAssist®8317270013738317270013732022-12-09
G0648317270013970TurnAssist®8317270013978317270013972022-12-09
G0648317270016631ULNAR NERVE PROTECTOR8317270016638317270016632022-12-09
G0648317270038580HEELIFT GLIDE® 8317270038588317270038582022-12-09
G0648317270041140HEEL/ELBOW PROTECTOR8317270041148317270041142022-12-09
G0648317270046640KNEE SEPARATOR8317270046648317270046642022-12-09
G0648317270052030HEELIFT GLIDE® Ultra8317270052038317270052032022-12-09
G0648317270053020HEELIFT AFO® Ultra 8317270053028317270053022022-12-09
G0648317270054010HEELIFT GLIDE® Ultra8317270054018317270054012022-12-09
G0648317270055000HEELIFT GLIDE® Ultra8317270055008317270055002022-12-09
G0648317270062790HEELIFT GLIDE® 8317270062798317270062792022-12-09
G0648317270064530HEELIFT GLIDE® 8317270064538317270064532022-12-09
G0648317270064600HEELIFT GLIDE® 8317270064608317270064602022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G064208317270091511CastWedge™POSITION HEALTH, LLCLGF2022-12-09
G064208317270092051CastWedge™POSITION HEALTH, LLCLGF2022-12-09
G064208317270093041CastWedge™POSITION HEALTH, LLCLGF2022-12-09
G064208317270091061CastWedge™ POSITION HEALTH, LLCLGF2022-12-09
00632195000659Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195001694Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002462Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002479Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002486Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002493Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002509Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195002516Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-12-15
00632195000505Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000529Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000543Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000567Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000581Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000604Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000628Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00632195000642Tex-Care MedicalFlynt/Amtex, Inc.LGF2021-10-29
00817740020072BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCLGF2017-04-25
10817740020079BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCLGF2017-04-25