FDA.reportPublic FDA data

MECRON Belt B: 22 cm, U: 66-86 cm

Primary DI
00609271950108
Brand
MECRON Belt B: 22 cm, U: 66-86 cm
Company
Darco (Europe) GmbH
Model
38-7320
Catalog number
38-7320
Device description
S White 3-tape bandage
Published
2023-02-14
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
IPXORTHOSIS, RIB FRACTURE, SOFT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPXOrthosis, Rib Fracture, SoftPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271950105PackageGS112In Commercial Distribution
00609271950108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195010510609271950105
00609271950108006092719501086092719501080609271950108

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446660576PROCAREDJO, LLCIPX2025-07-23
04823097721650"TM ""Rehabilitimed"" BR-2 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097721667"TM ""Rehabilitimed"" BR-2 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097721674"TM ""Rehabilitimed"" BR-2 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097721681"TM ""Rehabilitimed"" BR-2 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097721698"TM ""Rehabilitimed"" BR-2 XXL Comfort"REABILITIMED TOVIPX2025-06-19
04823097723678"TM ""Rehabilitimed"" BR-1 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097723685"TM ""Rehabilitimed"" BR-1 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097723692"TM ""Rehabilitimed"" BR-1 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097723708"TM ""Rehabilitimed"" BR-1 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097723715"TM ""Rehabilitimed"" BR-1 XXL Comfort"REABILITIMED TOVIPX2025-06-19
04823097706886"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706893"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706909"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706916"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706923"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706930"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
04823097706947"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706954"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706961"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706978"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706985"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706992"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
00609271950115MECRON Belt B: 22 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950122MECRON Belt B: 22 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14
00609271950139MECRON Belt B: 22 cm, U: 130-157 cmDarco (Europe) GmbHIPX2023-02-14
00609271950146MECRON Belt B: 29 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
00609271950153MECRON Belt B: 29 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950160MECRON Belt B: 29 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14
00609271950177MECRON Belt B: 29 cm, U: 130-157 cmDarco (Europe) GmbHIPX2023-02-14