FDA.reportPublic FDA data

NeoMatriX Wound Matrix

Primary DI
00860008106513
Brand
NeoMatriX Wound Matrix
Company
NEXTGEN BIOLOGICS INC
Model
FDSD0203
Catalog number
FDSD0203
Device description
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008106513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008106513008600081065138600081065130860008106513

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 209-7190RHINES@NWCRG.COM
(800) 209-7190jltoothman@nextgenbiologics.com

Regulatory Flags#

DUNS number
083272045
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008106582NeoMatriX Wound MatrixFDSD0103FDSD01032024-10-16
10860008106572NeoMatriX Wound MatrixFDSD0810FDSD08102022-08-17
00860008106506NeoMatriX Wound MatrixFDSD0307FDSD03072022-06-21
00860008106520NeoMatriX Wound MatrixFDSD0305FDSD03052022-06-21
00860008106544NeoMatriX Wound MatrixFDSD0102FDSD01022022-06-21
00860008106551NeoMatriX Wound MatrixFDSD0015FDSD00152022-06-21
00860008106568NeoMatriX Wound MatrixFDSD0010FDSD00102022-06-21
00860008106575NeoMatriX Wound MatrixFDSD0008FDSD00082022-06-21
00860008106537NeoMatriX Wound MatrixFDSD0507FDSD05072022-06-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
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05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
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