CellerateRX Surgical

GUDID 00850019972078

CellerateRX Surgical Hydrolyzed Collagen 1g Type I bovine collagen for chronic and acute wounds, partial and full thickness wounds, pressure injuries I-IV, venous stasis ulcers, arterial ulcers, diabetic ulcers, traumatic wounds, first and second degree burns, superficial wounds and surgical wounds. Sterile until opened. Store at room temperature. For use on moderately to heavily exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX Powder over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply 2-3 times a week, or with each dressing change, taking care not to disrupt wound site. https://sanaramedtech.com/surgical/celleraterx-surgical/

APPLIED NUTRITIONALS, LLC

Collagen wound matrix dressing

• Primary Device ID: 00850019972078
• NIH Device Record Key: cd4564db-e60a-4285-b86e-e78697e6aacf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellerateRX Surgical
• Version Model Number: WCI-01-SACRXP
• Company DUNS: 076872501
• Company Name: APPLIED NUTRITIONALS, 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: true

Customer Support Contacts

• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019972078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955506

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2023-03-20
• Device Publish Date: 2023-03-10

On-Brand Devices [CellerateRX Surgical ]

• 00850019972085: CellerateRX Surgical Hydrolyzed Collagen 5g Type I bovine collagen for chronic and acute wounds,
• 00850019972078: CellerateRX Surgical Hydrolyzed Collagen 1g Type I bovine collagen for chronic and acute wounds,