FDA.reportPublic FDA data

Wound Matrix

Primary DI
00813909012858
Brand
Wound Matrix
Company
NOVABONE PRODUCTS, LLC
Model
WM0145
Catalog number
WM0145
Device description
Collagen wound dressing
Published
2023-12-01
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

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
K220498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220498000NovoGen Wound MatrixNovabone Products, LLC2023-06-09KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813909012858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909012858008139090128588139090128580813909012858

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Length12Centimeter
Width4Inch
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828813290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813909013589Wound MatrixWM0122SPWM0122SP2026-02-17
00813909013596Wound MatrixWM0123SPWM0123SP2026-02-17
00813909013602Wound MatrixWM0133SPWM0133SP2026-02-17
00813909013619Wound MatrixWM0145SPWM0145SP2026-02-17
00813909013657Wound MatrixWM1011SPWM1011SP2026-02-17
00813909013664Wound MatrixWM1022SPWM1022SP2026-02-17
00813909013671Wound MatrixWM1044SPWM1044SP2026-02-17
00813909013695Wound MatrixWM1033SPWM1033SP2026-02-17
00813909012827Wound MatrixWM0122WM01222023-12-01
00813909012834Wound MatrixWM0123WM01232023-12-01
00813909012841Wound MatrixWM0133WM01332023-12-01
00813909013985Putty Syringe with Cannula 2.5ccNB6502NB65022026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNB6505NB65052026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNB6510NB65102026-01-28
00813909013961Putty Syringe 2.5ccNB2702CTNB2702CT2026-01-09
00813909013978Putty Syringe 5.0ccNB2705CTNB2705CT2026-01-09
00813909013909Putty 2.5ccNB0602NVNB0602NV2025-12-26
00813909013916Putty 5.0ccNB0605NVNB0605NV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNB1805NVNB1805NV2025-12-26
00813909013930Porous Morsels 1-2mm 10.0ccNB1810NVNB1810NV2025-12-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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