Vitale STRONG 20552

GUDID 00850005565741

Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case

CELLERA LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00850005565741
• NIH Device Record Key: d942c88f-8ffd-4b15-96d8-99970aa05a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitale STRONG
• Version Model Number: 20552
• Catalog Number: 20552
• Company DUNS: 960091929
• Company Name: CELLERA LLC
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005565734 [Primary]
GS1	00850005565741 [Package]; Contains: 00850005565734; Package: box [10 Units]; In Commercial Distribution
GS1	10850005565748 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143335

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: 2022-01-24
• Device Publish Date: 2022-01-16

On-Brand Devices [Vitale STRONG]

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• 00850005565574: Calcium Alginate Dressings, 4" x 8", 5/box, 10 boxes/case
• 00850005565550: Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case
• 00850005565529: Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
• 00850005565819: Calcium Alginate Dressings with Antibacterial Silver, 4" x 8", 5/box, 10 boxes/case
• 00850005565789: Calcium Alginate Dressings with Antibacterial Silver, 4" x 4", 10/box, 10 boxes/case
• 00850005565765: Calcium Alginate Dressings with Antibacterial Silver, 4" x 5", 10/box, 10 boxes/case
• 00850005565741: Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case
• 00850005565703: Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case
• 00850031608153: Calcium Alginate Dressings, 6" x 6", 1/pouch, 5/box, 10 boxes/case
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• 00850031608504: Silver Gelling Fiber Dressings 4"x8", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
• 00850031608481: Silver Gelling Fiber Dressings 4"x5", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack
• 00850031608467: Silver Gelling Fiber Dressings 4"x4", 1/pouch, 10/box, 10 boxes/case, 6 cases/overpack
• 00850031608443: Silver Gelling Fiber Dressings 2"x2", 1/pouch, 10/box, 10 boxes/case, 8 cases/overpack
• 00850031608429: Silver Gelling Fiber Ropes .8"x12", 1/pouch, 5/box, 10 boxes/case, 8 cases/overpack
• 00850031608405: Gelling Fiber Dressing 4" x 8", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
• 00850031608382: Gelling Fiber Dressing 4" x 5", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack
• 00850031608368: Gelling Fiber Dressing 4" x 4", 1/pouch, 10/box, 10 boxes/case, 6 cases/overpack
• 00850031608344: Gelling Fiber Dressing 2" x 2", 1/pouch, 10/box, 10 boxes/case, 8 cases/overpack
• 00850031608320: Gelling Fiber Rope .8" x 12", 1/pouch, 5/box, 10 boxes/case, 8 cases/overpack