FDA.reportPublic FDA data

KERRAPED PLUS™ All Purpose Boot

Primary DI
20609271000357
Brand
KERRAPED PLUS™ All Purpose Boot
Company
Darco (Europe) GmbH
Model
KPP1
Catalog number
KPP1
Device description
S Black Round-toe
Published
2023-02-13
Public version status
Update
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
KNPORTHOSIS, CORRECTIVE SHOE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271000350PackageGS112In Commercial Distribution
20609271000357PackageGS136In Commercial Distribution
00609271000353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100035010609271000350
2060927100035720609271000357
00609271000353006092710003536092710003530609271000353

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343551081
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
true
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
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
00609271120297POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120334POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120501POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271000353KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000360KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000377KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271001428DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001435DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001442DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001459DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001466DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001473DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001480DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001497DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271010116DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010215DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010314DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010413DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013117DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013216DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013315DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271016514DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230569DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230576DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230583DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230613DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230620DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230637DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230668DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13