FDA.reportPublic FDA data

HealiAid Collagen Wound Dressing

Primary DI
04714691221083
Brand
HealiAid Collagen Wound Dressing
Company
MAXIGEN BIOTECH INC.
Model
HA101005
Published
2024-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K223126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223126000SurgiAid® Collagen Wound DressingMaxigen Biotech, Inc.2023-10-11KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04714691221083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04714691221083047146912210834714691221083

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

Regulatory Flags#

DUNS number
657266016
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04714691213958VeraFill Dental Collagen Wound DressingHAD0015202026-03-30
04714691213132Omniplug Collagen Wound DressingHAD0010202024-07-26
04714691213170Omniplug Collagen Wound Dressing HAD0015202024-07-26
04714691213477HealiAid Dental Collagen Wound DressingHAD0010202024-07-26
04714691213484HealiAid Dental Collagen Wound Dressing HAD0015202024-07-26
04714691213552HealiAid Dental Collagen Wound DressingHADB1010302024-11-18
04714691213569HealiAid Dental Collagen Wound DressingHADB1515302024-11-18
04714691213576HealiAid Dental Collagen Wound DressingHADB1504302024-11-18
04714691850443Curagen collagen wound dressingHAD2040302024-11-18
04714691850450Curagen collagen wound dressingHAD0015202024-11-18
04714691850467Curagen collagen wound dressingHAD0010202024-11-18
04714691213460HealiAid Dental Collagen Wound DressingHAD0010202024-07-22
04714691213019HealiAid Dental Collagen Wound DressingHAD1520052024-01-31
04714691213026HealiAid Dental Collagen Wound DressingHAD2030052024-01-31
04714691213033HealiAid Dental Collagen Wound DressingHAD2530052024-01-31
04714691213040HealiAid Dental Collagen Wound DressingHAD3040052024-01-31
04714691213057HealiAid Dental Collagen Wound DressingHADB1520302024-01-31
04714691213064HealiAid Dental Collagen Wound DressingHADB2530302024-01-31
04714691213071HealiAid Dental Collagen Wound DressingHAD2040302024-01-31
04714691213088HealiAid Dental Collagen Wound DressingHADB3040302024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008106599NeoMatriX Wound MatrixNEXTGEN BIOLOGICS INCKGN2026-10-21
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09421908222584Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
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