| Primary Device ID | 00850019972092 |
| NIH Device Record Key | 5e76e64e-9394-47be-a816-9f5811c67930 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CellerateRX |
| Version Model Number | CRXG-28GMEA |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019972092 [Primary] |
| KGN | Wound Dressing With Animal-Derived Material(S) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-20 |
| Device Publish Date | 2023-07-12 |
| 00850019972092 - CellerateRX | 2023-07-20CellerateRX 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. |
| 00850019972092 - CellerateRX | 2023-07-20 CellerateRX is Type I bovine hydrolyzed collagen gel for chronic and acute wounds including partial and full-thickness wounds, p |
| 00850019972078 - CellerateRX Surgical | 2023-03-20 CellerateRX Surgical Hydrolyzed Collagen 1g Type I bovine collagen for chronic and acute wounds, partial and full thickness woun |
| 00850019972085 - CellerateRX Surgical | 2023-03-20 CellerateRX Surgical Hydrolyzed Collagen 5g Type I bovine collagen for chronic and acute wounds, partial and full thickness woun |