FDA.reportPublic FDA data

KerraCel

Primary DI
05060077231368
Brand
KerraCel
Company
CRAWFORD HEALTHCARE LIMITED
Model
1 x 18 in
Catalog number
CWL1035
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

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
05060077231054PackageGS110In Commercial Distribution
05060077231351PackageGS15In Commercial Distribution
05060077231368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060077231054050600772310545060077231054
05060077231351050600772313515060077231351
05060077231368050600772313685060077231368

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Inch
Length18Inch

Storage And Handling#

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

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
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
05060077232495KerraFoam Gentle Border4 x 10inCWL11332019-10-01

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Primary DI, Brand, Company table
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