FDA.reportPublic FDA data

Gripper Hinged Knee

Primary DI
00802357170173
Brand
Gripper Hinged Knee
Company
MEDICAL SPECIALTIES INCORPORATED
Model
117017
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00802357170173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357170173008023571701738023571701730802357170173

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
003173028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14
00802357240067TRIPOD WRIST LACER II2240062025-01-14
00802357240111TRIPOD WRIST LACER II2240112025-01-14
00802357240128TRIPOD WRIST LACER II2240122025-01-14
00802357240142TRIPOD WRIST LACER II2240142025-01-14
00802357240159TRIPOD WRIST LACER II2240152025-01-14
00802357240166TRIPOD WRIST LACER II2240162025-01-14
00802357130702Prosplints1130702022-12-07
00802357130719Prosplints1130712022-12-07
00802357230815Tee Pee Thumb Protector2230812022-12-07
00802357230822Tee Pee Thumb Protector2230822022-12-07
00802357230853Tee Pee Thumb Protector2230852022-12-07
00802357230860Tee Pee Thumb Protector2230862022-12-07
00802357231805Suede Thumb Support2231802022-12-07
00802357231904Suede Thumb support2231902022-12-07
00802357232215Wrist Lacer2232212022-12-07

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Primary DI, Brand, Company table
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00810179882426CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882488CopperfitIdeavillage Products CorpITQ2026-10-01
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00810179882624CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882631CopperfitIdeavillage Products CorpITQ2026-10-01
00810226441538ViveVIVE HEALTH LLCITQ2026-08-03
00049696508377THERA PlusFOURSTAR GROUP INC.ITQ2026-06-09
00810178889280CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889297CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889303CoreTechVIVE HEALTH LLCITQ2026-05-05
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00810178889327CoreTechVIVE HEALTH LLCITQ2026-05-05
00057475210434BIOS LivingThermor LtdITQ2023-03-31
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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