KerraCel CWL1035

GUDID 05060077231351

CRAWFORD HEALTHCARE LIMITED

Exudate-absorbent dressing, hydrophilic-gel, sterile Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

• Primary Device ID: 05060077231351
• NIH Device Record Key: 65e960fa-6115-4544-968b-5b444fc2d1b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KerraCel
• Version Model Number: 1 x 18 in
• Catalog Number: CWL1035
• Company DUNS: 543740310
• Company Name: CRAWFORD HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch
• Height: 1 Inch
• Length: 18 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060077231054 [Package]; Package: Shipper [10 Units]; In Commercial Distribution
GS1	05060077231351 [Package]; Contains: 05060077231368; Package: Carton [5 Units]; In Commercial Distribution
GS1	05060077231368 [Primary]

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [KerraCel]

• 05060077233751: 4 x 4in
• 05060077231351: 1 x 18 in
• 05060077231344: 6 x 6in
• 05060077231313: 4 x 5in
• 05060077231290: 2 x 2in