CellerateRX Surgical

Primary DI
00850019972085
Brand
CellerateRX Surgical
Company
APPLIED NUTRITIONALS, LLC
Model
WCI-05-SACRXP
Device description
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/
Published
2023-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955506000HYCUREThe Hymed Group Corp.1996-01-17KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019972085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019972085008500199720858500199720850850019972085

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-205-7719customerservice@sanaramedtech.com

Regulatory Flags#

DUNS number
076872501
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019972092CellerateRXCRXG-28GMEA2023-07-12
00850019972078CellerateRX Surgical WCI-01-SACRXP2023-03-10

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