CellerateRX

Basic Information

• Brand Name: CellerateRX
• Primary DI: 00850019972092
• Version / Model: CRXG-28GMEA
• Company Name: APPLIED NUTRITIONALS, LLC
• Labeler DUNS: 076872501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-12
• Public Version: 2
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: 5e76e64e-9394-47be-a816-9f5811c67930

Device Description

CellerateRX is Type I bovine hydrolyzed collagen gel for chronic and acute wounds including partial and full-thickness wounds, pressure injuries 1-4, venous stasis ulcers, arterial ulcers, diabetic ulcers, surgical wounds, traumatic wounds, first and second-degree burns, and superficial wounds. Sterile until opened. Store at room temperature. For use in management of lightly to moderately exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply CellerateRX a minimum of 2-3 times per week, or with each dressing change, taking care not to disrupt the wound site. www.sanaramedtech.com.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850019972092	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955506	000