HealiAid

Primary DI
04714691850177
Brand
HealiAid
Company
MAXIGEN BIOTECH INC.
Model
SA304005
Catalog number
SA304005
Device description
HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collagen, purified from bovine Achilles tendons. HealiAid can greatly enchance and accelerate tissue ingrowth and support bone augmentation. SA304005 size: 30mm x 40mm x 5mm
Published
2019-07-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
04714691850177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04714691850177047146918501774714691850177

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
951 757 3535juan.lucero911@gmail.com

Regulatory Flags#

DUNS number
657266016
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31