KerraCel CWL1033

GUDID 05060077231313

CRAWFORD HEALTHCARE LIMITED

Exudate-absorbent dressing, hydrophilic-gel, sterile
Primary Device ID05060077231313
NIH Device Record Keyc8e00068-5139-46e6-ad18-3ac4d1cd128e
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerraCel
Version Model Number4 x 5in
Catalog NumberCWL1033
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+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com
Phone+4401565654920
Emailandrew.jackson@acelity.com

Device Dimensions

Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch
Length4 Inch
Height5 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060077231313 [Package]
Contains: 05060077231320
Package: Carton [10 Units]
In Commercial Distribution
GS105060077231320 [Primary]
GS105060077234291 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Product Code

NACDressing, Wound, Hydrophilic

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 [KerraCel]

050600772337514 x 4in
050600772313511 x 18 in
050600772313446 x 6in
050600772313134 x 5in
050600772312902 x 2in

Trademark Results [KerraCel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KERRACEL
KERRACEL
86318943 4832946 Live/Registered
SYSTAGENIX WOUND MANAGEMENT, LIMITED
2014-06-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.