FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
10779709020431
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
RTL2043
Device description
Personal CareAids to Daily Living Product Description: Plastic Shoehorn,Medium BL,16",1EA,3/CS
Published
2019-06-21
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILDADAPTOR, DRESSING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILDAdaptor, DressingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10779709020431PackageGS136Not in Commercial Distribution
50779709020439PackageGS13Not in Commercial Distribution
00779709020434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1077970902043110779709020431
5077970902043950779709020439
00779709020434007797090204347797090204340779709020434

GMDN Terms#

Term, Definition table
TermDefinition
Assistive shoehorn/bootjackA device designed as a modified shoehorn or bootjack to assist a person with a disability to put on and take off their footwear (shoes or boots).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818323022797ViveVIVE HEALTH LLCILD2026-05-11
00818323025279ViveVIVE HEALTH LLCILD2026-05-11
05050962001534EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962023048LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962057791SOXONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962080065LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110168REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110175REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146372REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146389REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156210REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156227REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156234REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156241REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156258REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156265SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962161269SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962164192EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171152HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171169HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177895HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177918HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962203983ARTHRI GRIPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962355002EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
00023601042248CarexDrive Devilbiss HealthcareILD2024-01-08
00023601042255CarexDrive Devilbiss HealthcareILD2023-09-29
30023601042256CarexCOMPASS HEALTH BRANDS CORP.ILD2023-09-29
00840252902925Cushion GripTherafin CorporationILD2023-07-06
00840252902949Cushion GripTherafin CorporationILD2023-07-06
00840252902963Cushion GripTherafin CorporationILD2023-07-06