FDA.reportPublic FDA data

KerraMax Care

Primary DI
05060077230767
Brand
KerraMax Care
Company
CRAWFORD HEALTHCARE LIMITED
Model
4 x 9in
Catalog number
PRD500-120
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060077230132PackageGS110In Commercial Distribution
05060077232204PackageGS170In Commercial Distribution
05060077232402PackageGS150In Commercial Distribution
05060077232419PackageGS112In Commercial Distribution
05060077230767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060077230132050600772301325060077230132
05060077232204050600772322045060077232204
05060077232402050600772324025060077232402
05060077232419050600772324195060077232419
05060077230767050600772307675060077230767

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store away from direct sunlight
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

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

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Primary DI, Brand, Company table
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