FDA.reportPublic FDA data

MECRON Shoulder Classic

Primary DI
00609271950016
Brand
MECRON Shoulder Classic
Company
Darco (Europe) GmbH
Model
38-003
Catalog number
38-003
Device description
S White
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
IQJSPLINT, CLAVICLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQJSplint, ClaviclePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271950013PackageGS112In Commercial Distribution
00609271950016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195001310609271950013
00609271950016006092719500166092719500160609271950016

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. 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
00609271950382MECRON Knee Flexion L:500mm, OS:540mm, US:330mmOH500304OH5003042023-02-08
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

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