KerraLite Cool Border CWL1009

GUDID 05060077230675

CRAWFORD HEALTHCARE LIMITED

Wound hydrogel dressing, sterile
Primary Device ID05060077230675
NIH Device Record Key894e0c5b-5e92-41df-b756-1ee7a82f7b5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerraLite Cool Border
Version Model Number6x6in
Catalog NumberCWL1009
Company DUNS543740310
Company NameCRAWFORD HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com
Phone+44 1565654920
Emailandrew.jackson@acelity.com

Device Dimensions

Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch
Length6 Inch
Height6 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105060077230675 [Package]
Contains: 05060077231283
Package: Carton [5 Units]
In Commercial Distribution
GS105060077231283 [Primary]
GS105060077232754 [Package]
Package: Shipper [32 Units]
In Commercial Distribution

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-09
Device Publish Date2019-10-01

On-Brand Devices [KerraLite Cool Border]

050600772306756x6in
05060077230668Soothing, debriding and moisture-balancing dressing.
050600772306513x3in

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