FDA.reportPublic FDA data

KerraFoam Gentle Border

Primary DI
05060077232464
Brand
KerraFoam Gentle Border
Company
CRAWFORD HEALTHCARE LIMITED
Model
6 x 6in
Catalog number
CWL1132
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060077232471PackageGS110In Commercial Distribution
05060077232488PackageGS14In Commercial Distribution
05060077232464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060077232471050600772324715060077232471
05060077232488050600772324885060077232488
05060077232464050600772324645060077232464

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

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
05060077232495KerraFoam Gentle Border4 x 10inCWL11332019-10-01

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