FDA.reportPublic FDA data

KerraPro

Primary DI
05060077230422
Brand
KerraPro
Company
CRAWFORD HEALTHCARE LIMITED
Model
Heel
Catalog number
KPRO30
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060077230408PackageGS12In Commercial Distribution
05060077234086PackageGS132In Commercial Distribution
05060077230422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060077230408050600772304085060077230408
05060077234086050600772340865060077234086
05060077230422050600772304225060077230422

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-management bandage, siliconeA non-sterile piece of silicone material intended to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility. It is available in various shapes (e.g.,, concave shapes for the heel or elbow, pads for the sacrum, and sheets or strips for other areas of the body) and sizes, and may be used in a healthcare facility or in the home. This is a single-patient, reusable device.

Contacts#

Phone, Email table
PhoneEmail
+4401565654920andrew.jackson@acelity.com
+4401565654920elizabeth.woods@acelity.com

Regulatory Flags#

DUNS number
543740310
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060077231306KerraCel2 x 2inCWL10322019-10-01
05060077231320KerraCel4 x 5inCWL10332019-10-01
05060077231368KerraCel1 x 18 inCWL10352019-10-01
05060077233508KerraCel Ag2 x 2inCWL11572019-10-01
05060077233539KerraCel Ag4 x 5inCWL11582019-10-01
05060077233560KerraCel Ag6 x 6inCWL1159 2019-10-01
05060077233591KerraCel Ag8 x 12inCWL11602019-10-01
05060077233652KerraCel Ag0.75 x 18inCWL11622019-10-01
05060077233683KerraCel Ag16 x 16inCWL11632019-10-01
05060077233744KerraCel4 x 4inCWL11662019-10-01
05060077233973KerraCel Ag0.75 x 12inCWL11682019-10-01
05060077231344KerraCel6 x 6inCWL10342019-10-01
05060077230828KerraFoam Gentle Border3 x 3inCWL10102019-10-01
05060077230835KerraFoam Gentle Border4 x 4inCWL10112019-10-01
05060077230842KerraFoam Gentle Border4 x 8inCWL10122019-10-01
05060077230859KerraFoam Gentle Border5 x 5inCWL10132019-10-01
05060077230989KerraFoam Gentle Border9.8 x 9inCWL10242019-10-01
05060077230996kerraFoam Gentle Border6.7 x 6.9inCWL10232019-10-01
05060077231382KerraFoam Gentle Border9 x 10inCWL10402019-10-01
05060077232464KerraFoam Gentle Border6 x 6inCWL11322019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
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05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08