FDA.reportPublic FDA data

20'' DLX 3-PANEL KNEE IMMOB

Primary DI
00609271210806
Brand
20'' DLX 3-PANEL KNEE IMMOB
Company
DARCO INTERNATIONAL, INC.
Model
462-0028-10
Catalog number
462-0028-10
Device description
Universal
Published
2023-02-08
Public version status
Update
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
10609271210803PackageGS14In Commercial Distribution
20609271210800PackageGS112In Commercial Distribution
00609271210806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927121080310609271210803
2060927121080020609271210800
00609271210806006092712108066092712108060609271210806

GMDN Terms#

Term, Definition table
TermDefinition
Knee splintA rigid, non-articulating, external support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.

Regulatory Flags#

DUNS number
184231298
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
00609271999336Aircore™ Offloading InsoleACI02026-07-20
00609271999343Aircore™ Offloading InsoleACI12026-07-20
00609271999374Aircore™ Offloading InsoleACI42026-07-20
00609271999381Aircore™ Offloading InsoleACI52026-07-20
00609271999473Aircore™ Offloading InsoleACI22026-07-20
00609271999480Aircore™ Offloading InsoleACI32026-07-20
00609271989603Aircore™ Offloading InsoleACIP0602026-01-07
00609271989610Aircore™ Offloading InsoleACIP0702026-01-07
00609271989627Aircore™ Offloading InsoleACIP0752026-01-07
00609271989634Aircore™ Offloading InsoleACIP0802026-01-07
00609271989658Aircore™ Offloading InsoleACIP0902026-01-07
00609271989665Aircore™ Offloading InsoleACIP0952026-01-07
00609271989672Aircore™ Offloading InsoleACIP1002026-01-07
00609271989689Aircore™ Offloading InsoleACIP1052026-01-07
00609271989696Aircore™ Offloading InsoleACIP1102026-01-07
00609271989702Aircore™ Offloading InsoleACIP1152026-01-07
00609271989719Aircore™ Offloading InsoleACIP1202026-01-07
00609271989726Aircore™ Offloading InsoleACIP1252026-01-07
00609271989733Aircore™ Offloading InsoleACIP1302026-01-07
00609271989740Aircore™ Offloading InsoleACIP1352026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882389CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882396CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882419CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882426CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882488CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882495CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882501CopperfitIdeavillage Products CorpITQ2026-10-01
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
00810178889310CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889327CoreTechVIVE HEALTH LLCITQ2026-05-05
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
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08