FDA.reportPublic FDA data

Elite Orthopaedics

Primary DI
00816591011024
Brand
Elite Orthopaedics
Company
Elite Orthopaedics, Inc.
Model
K30026
Catalog number
K30026
Device description
Neoprene Hinged Knee Wrap, Large
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816591011024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816591011024008165910110248165910110240816591011024

GMDN Terms#

Term, Definition table
TermDefinition
Knee support orthosisA stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803168228
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816591010690Elite Orthopaedics30061-R30061-R2023-08-17
00816591010706Elite Orthopaedics30061-L30061-L2023-08-17
00816591010713Elite Orthopaedics30062-R30062-R2023-08-17
00816591010720Elite Orthopaedics30062-L30062-L2023-08-17
00816591010737Elite Orthopaedics30063-R30063-R2023-08-17
00816591010744Elite Orthopaedics30063-L30063-L2023-08-17
00816591010751Elite Orthopaedics30064-R30064-R2023-08-17
00816591010768Elite Orthopaedics30064-L30064-L2023-08-17
00816591010775Elite Orthopaedics30065-R30065-R2023-08-17
00816591010782Elite Orthopaedics30065-L30065-L2023-08-17
00816591010799Elite Orthopaedics31061-R31061-R2023-08-18
00816591010805Elite Orthopaedics31062-R31062-R2023-08-18
00816591010812Elite Orthopaedics31063-R31063-R2023-08-18
00816591010829Elite Orthopaedics31064-R31064-R2023-08-18
00816591010836Elite Orthopaedics31065-R31065-R2023-08-18
00816591010843Elite Orthopaedics31061-L31061-L2023-08-18
00816591010850Elite Orthopaedics31062-L31062-L2023-08-18
00816591010867Elite Orthopaedics31063-L31063-L2023-08-18
00816591010874Elite Orthopaedics31064-L31064-L2023-08-18
00816591010881Elite Orthopaedics31065-L31065-L2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00057475210434BIOS LivingThermor LtdITQ2023-03-31
0060927120013516'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610842"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610859"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610866"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610873"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610880"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610897"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610903"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610910"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610927"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08