FDA.reportPublic FDA data

MECRON Belt B: 22 cm, U: 105-127 cm

Primary DI
10609271950129
Brand
MECRON Belt B: 22 cm, U: 105-127 cm
Company
DARCO INTERNATIONAL, INC.
Model
38-7340
Catalog number
38-7340
Device description
L White 3-tape bandage
Published
2023-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10609271950129PackageGS112In Commercial Distribution
00609271950122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195012910609271950129
00609271950122006092719501226092719501220609271950122

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"E59411E594112023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"E59412E594122023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"E59413E594132023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"E59414E594142023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"E59415E594152023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"E59416E594162023-02-08

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
00609271950108MECRON Belt B: 22 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
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