CalciCare 529967R

GUDID 20610075029574

Calcium Alginate Silver Dressing

HOLLISTER INCORPORATED

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

• Primary Device ID: 20610075029574
• NIH Device Record Key: 2b3aebfc-bec6-47ef-9ca8-9075480eede0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalciCare
• Version Model Number: 529967R
• Catalog Number: 529967R
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 10
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com

Device Dimensions

• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter
• Width: 5 Centimeter
• Height: 5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610075029577 [Primary]
GS1	20610075029574 [Package]; Contains: 10610075029577; Package: CAS [10 Units]; In Commercial Distribution
GS1	30610075029571 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090453

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-30
• Device Publish Date: 2022-11-01

On-Brand Devices [CalciCare]

• 20610075029567: Calcium Alginate Dressing
• 20610075029550: Calcium Alginate Dressing
• 20610075029543: Calcium Alginate Dressing
• 20610075029536: Calcium Alginate Dressing
• 20610075029598: Calcium Alginate Silver Dressing
• 20610075029581: Calcium Alginate Silver Dressing
• 20610075029574: Calcium Alginate Silver Dressing