AccessGUDID - DEVICE: CellerateRX (00850019972092)

GUDID

Device Identifier (DI) Information

Brand Name: CellerateRX
Version or Model: CRXG-28GMEA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED NUTRITIONALS, LLC

Primary DI Number: 00850019972092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076872501 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Wound Dressing With Animal-Derived Material(S)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955506	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e76e64e-9394-47be-a816-9f5811c67930
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023