Vitale 22000

GUDID 00850005565208

Vitale Collagen Powder, 1 gram/packet, 10 packets/box, 10 boxes/case, 8 cases/overpack

CELLERA LLC

Collagen wound matrix dressing

• Primary Device ID: 00850005565208
• NIH Device Record Key: 976c75ad-b7a4-4deb-b7e8-a5bc3f24cb2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitale
• Version Model Number: 22000
• Catalog Number: 22000
• 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: false
• 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
• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005565185 [Primary]
GS1	00850005565192 [Package]; Contains: 00850005565185; Package: box [10 Units]; In Commercial Distribution
GS1	00850005565208 [Package]; Contains: 10850005565199; Package: overpack [8 Units]; In Commercial Distribution
GS1	10850005565199 [Package]; Contains: 00850005565192; Package: case [10 Units]; In Commercial Distribution
GS1	20850005565196 [Package]; Contains: 10850005565199; Package: overpack [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030921

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-05-24

On-Brand Devices [Vitale]

• 10856276008786: Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
• 10856276008762: Vitale Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case
• 10856276008748: Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
• 10856276008724: Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case
• 10856276008700: Vitale Calcium Alginate Dressings with Antimicrobial Silver, 4" x 5", 10/box, 10 boxes/case
• 10856276008687: Vitale Non-Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case
• 10856276008663: Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case
• 10856276008649: Vitale Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case
• 10856276008625: Vitale Foam Heel Dressings, 6" x 7", 5/box, 10 boxes/case
• 10856276008601: Vitale Adhesive Foam Dressings, 6" x 6", 10/box, 10 boxes/case
• 10856276008588: Vitale Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case
• 00856276008567: Vitale Sacral Silicone Dressings, 1/pouch, 5/box, 40 boxes/case
• 10856276008533: Vitale Hydroconductive Dressings, 6" x 8", 1/pouch, 10/box, 10 boxes/case
• 10856276008519: Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• 10856276008496: Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
• 10856276008472: Vitale Cover Dressings, 4" x 14", 20/box, 10 boxes/case
• 10856276008434: Vitale Sacral Hydrocolloid Dressings, 6" x 7", 1/pouch, 10/box, 10 boxes/case
• 10856276008410: Vitale Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• 10856276008397: Vitale Calcium Alginate Ropes, 5/box, 10 boxes/case
• 00856276008352: Vitale Composite dressings, 6" x 6", 1/pouch, 30/box, 8 boxes/case
• 10856276008229: Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
• 00856276008208: Vitale Silicone Foam Dressings, 6" x 6", 10/box, 10 boxes/case, 4 cases/overpack
• 10856276008175: Vitale Hydroconductive Dressings, 4" x 5", 1/pouch, 10/box, 10 boxes/case
• 00856276008154: Vitale Silicone Foam Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack
• 10856276008120: Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case
• 00856276008109: Vitale Composite Dressings, 1/pouch, 30/box, 8 boxes/case
• 10856276008083: Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• 00856276008062: Vitale Hydroconductive Dressings, 2"x2", 1/pouch, 10/box, 10 boxes/case
• 00856276008055: Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case
• 10856276008281: Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case
• 00856276008017: Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
• 00856276008253: Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 cases/overpack
• 10850005565038: Vitale Sacral Silicone Super-Absorbent Dressings, 5/box, 10 boxes/case
• B492245062: Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
• B492245042: Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
• B492245022: Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case
• B492238440: Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
• B492238222: Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case
• B492212900: Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
• B492212442: Vitale Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• B492212222: Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
• B492210442: Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• B492208452: Vitale Hydroconductive Dressings, 4" x 5", 1/pouch, 10/box, 10 boxes/case
• B492208442: Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
• B492208222: Vitale Hydroconductive Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
• B492208002: Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case
• B492206452: Vitale Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case
• B492206442: Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
• B492206222: Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case
• B492206002: Vitale Calcium Alginate Ropes, 5/box, 10 boxes/case