CellerateRX Surgical

GUDID 00850019972085

CellerateRX Surgical Hydrolyzed Collagen 5g 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 ID00850019972085
NIH Device Record Key9989a883-aba1-40ec-b268-e711bd32b9fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCellerateRX Surgical
Version Model NumberWCI-05-SACRXP
Company DUNS076872501
Company NameAPPLIED NUTRITIONALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com
Phone800-205-7719
Emailcustomerservice@sanaramedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019972085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-20
Device Publish Date2023-03-10

On-Brand Devices [CellerateRX Surgical]

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

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