FDA.report

Corplex P

Primary DI
00860471002565
Brand
Corplex P
Company
Stimlabs LLC
Model
2 cc
Catalog number
CP0020
Device description
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications

CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860471002565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860471002565008604710025658604710025650860471002565

GMDN Terms

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

Contacts

PhoneEmail
1-(888) 346-9802customerservice@stimlabs.com

Regulatory Flags

DUNS number
067529916
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850039927348Allacor P1 ccAP-00102025-03-05
00850039927355Allacor P2 ccAP-00202025-03-05
00850039927362Allacor P4 ccAP-00402025-03-05
00860471002558Corplex P1 ccCP-00102024-07-29
00860471002572Corplex P4 ccCP-00402024-07-29

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