KerraFoam Gentle Border CWL1013

GUDID 05060077232648

CRAWFORD HEALTHCARE LIMITED

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

• Primary Device ID: 05060077232648
• NIH Device Record Key: 4264fe5d-f68b-4ef8-b198-98383cff5803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KerraFoam Gentle Border
• Version Model Number: 5 x 5in
• Catalog Number: CWL1013
• 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

• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 Inch
• Length: 5 Inch
• Height: 5 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
• 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	05060077230729 [Package]; Contains: 05060077230859; Package: Carton [10 Units]; In Commercial Distribution
GS1	05060077230859 [Primary]
GS1	05060077232648 [Package]; Contains: 05060077230729; Package: Shipper [10 Units]; In Commercial Distribution

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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 [KerraFoam Gentle Border]

• 05060077232617: 7 x 8in
• 05060077232549: 4 x 12in
• 05060077232518: 4 x 10in
• 05060077232488: 6 x 6in
• 05060077231399: 9 x 10in
• 05060077232662: 6.7 x 6.9in
• 05060077232679: 9.8 x 9in
• 05060077232648: 5 x 5in
• 05060077232655: 4 x 8in
• 05060077232631: 4 x 4in
• 05060077230699: 3 x 3in