FDA.reportPublic FDA data

MECRON Knee Flexion L:500mm, OS:540mm, US:330mm

Primary DI
00609271950382
Brand
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm
Company
Darco (Europe) GmbH
Model
OH500304
Catalog number
OH500304
Device description
L Black 20° / 50 cm
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
10609271950389PackageGS112In Commercial Distribution
00609271950382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195038910609271950389
00609271950382006092719503826092719503820609271950382

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
343551081
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
00609271950238MECRON Knee Flexion L:400mm, OS:430mm, US:300mmOH400104OH4001042023-02-08
00609271950269MECRON Knee Flexion L:400mm, OS:480mm, US:350mmOH400204OH4002042023-02-08
00609271950290MECRON Knee Flexion L:400mm, OS:530mm, US:400mmOH400304OH4003042023-02-08
00609271950320MECRON Knee Flexion L:500mm, OS:440mm, US:230mmOH500104OH5001042023-02-08
00609271950351MECRON Knee Flexion L:500mm, OS:490mm, US:280mmOH500204OH5002042023-02-08
00609271950412MECRON Knee Flexion L:500mm, OS:590mm, US:380mmOH500404OH5004042023-02-08
00609271950443MECRON Knee Flexion L:600mm, OS:450mm, US:220mmOH600104OH6001042023-02-08
00609271950474MECRON Knee Flexion L:600mm, OS:500mm, US:270mmOH600204OH6002042023-02-08
00609271950504MECRON Knee Flexion L:600mm, OS:550mm, US:320mmOH600304OH6003042023-02-08
00609271950535MECRON Knee Flexion L:600mm, OS:600mm, US:350mmOH600404OH6004042023-02-08
00609271950559MECRON Knee 3-partOH655124OH6551242023-02-08
00609271950573MECRON Knee 3-partOH655324OH6553242023-02-08
00609271950597MECRON Knee 3-partOH655524OH6555242023-02-08
00609271950917MECRON Knee PediatricOS302001OS3020012023-02-08
00609271950924MECRON Knee PediatricOS303001OS3030012023-02-08
00609271950931MECRON Knee PediatricOS304001OS3040012023-02-08
00609271950962MECRON Knee Straight L:400mm, OS:430mm, US:300mmOS400104OS4001042023-02-08
00609271950993MECRON Knee Straight L:400mm, OS:480mm, US:350mmOS400204OS4002042023-02-08
00609271951020MECRON Knee Straight L:400mm, OS:530mm, US:400mmOS400304OS4003042023-02-08
00609271951082MECRON Knee Straight L:500mm, OS:440mm, US:230mmOS500104OS5001042023-02-08

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
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08