KerraLite Cool Border CWL1008

GUDID 05060077230668

Soothing, debriding and moisture-balancing dressing.

CRAWFORD HEALTHCARE LIMITED

Wound hydrogel dressing, sterile
Primary Device ID05060077230668
NIH Device Record Key20ceea7c-3fcc-40ad-904b-77055bf194d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerraLite Cool Border
Version Model Number4x4in
Catalog NumberCWL1008
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

Device Dimensions

Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 Inch
Length4 Inch
Height4 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
GS105060077230668 [Package]
Contains: 05060077231276
Package: Carton [5 Units]
In Commercial Distribution
GS105060077231276 [Primary]
GS105060077232747 [Package]
Package: Shipper [52 Units]
In Commercial Distribution
GS105060077233805 [Package]
Contains: 05060077231276
Package: Shipper [550 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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