Restore 529969

GUDID 30894689001936

Calcium Alginate Dressing, Silver

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: 30894689001936
• NIH Device Record Key: 20ec9909-9f4f-46c7-a641-3f4fef66f7bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore
• Version Model Number: 529969
• Catalog Number: 529969
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 5
• 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

• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 Centimeter
• Height: 30 Centimeter
• Length: 30.5 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	00894689001904 [Unit of Use]
GS1	00894689001935 [Primary]
GS1	30894689001936 [Package]; Contains: 00894689001935; Package: CAS [10 Units]; In Commercial Distribution

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 [Restore]

• 30894689001851: Calcium Alginate Dressing
• 30894689001844: Calcium Alginate Dressing
• 30894689001837: Calcium Alginate Dressing
• 30894689001820: Calcium Alginate Dressing
• 20610075043570: Hydrocolloid Dressing with Tapered Edge
• 20610075043563: Hydrocolloid Dressing with Tapered Edge
• 20610075043556: Hydrocolloid Dressing with Tapered Edge
• 20610075043549: Hydrocolloid Dressing with Tapered Edge
• 20610075043532: Hydrocolloid Dressing with Tapered Edge
• 30894689001967: Hydrocolloid Dressing with Tapered Edge
• 20610075043518: Hydrocolloid Dressing
• 20610075043501: Hydrocolloid Dressing
• 30894689001950: Hydrocolloid Dressing
• 20610075043488: Hydrocolloid Dressing with Foam Backing
• 20610075043471: Hydrocolloid Dressing with Foam Backing
• 20610075043464: Hydrocolloid Dressing with Foam Backing
• 20610075043457: Extra Thin Hydrocolloid Dressing
• 20610075043440: Extra Thin Hydrocolloid Dressing
• 30894689001943: Extra Thin Hydrocolloid Dressing
• 10610075059789: Dermal Wound Cleanser
• 10610075059772: Dermal Wound Cleanser
• 30894689001936: Calcium Alginate Dressing, Silver
• 30894689001929: Calcium Alginate Dressing, Silver
• 30894689001912: Calcium Alginate Dressing, Silver