KerraCel Ag CWL1158

GUDID 05060077233553

CRAWFORD HEALTHCARE LIMITED

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

• Primary Device ID: 05060077233553
• NIH Device Record Key: 0bbc07dc-9ffb-4985-b2be-2310568306d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KerraCel Ag
• Version Model Number: 4 x 5in
• Catalog Number: CWL1158
• Company DUNS: 543740310
• Company Name: CRAWFORD HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com
• Phone: +4401565654920
• Email: andrew.jackson@acelity.com

Device Dimensions

• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 Inch
• Length: 5 Inch
• Height: 4 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	05060077233539 [Primary]
GS1	05060077233546 [Package]; Contains: 05060077233539; Package: Carton [10 Units]; In Commercial Distribution
GS1	05060077233553 [Package]; Contains: 05060077233546; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162508

FDA Product Code

• FRO: Dressing, Wound, Drug

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 Ag]

• 05060077233997: 0.75 x 12in
• 05060077233706: 16 x 16in
• 05060077233676: 0.75 x 18in
• 05060077233614: 8 x 12in
• 05060077233584: 6 x 6in
• 05060077233553: 4 x 5in
• 05060077233522: 2 x 2in