FDA.reportPublic FDA data

HealiAid

Primary DI
04714691850023
Brand
HealiAid
Company
MAXIGEN BIOTECH INC.
Model
SA001020
Catalog number
SA001020
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. SA001020 size: 10(dia) x 20mm
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

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
04714691850023PrimaryGS10
04714691850283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04714691850023047146918500234714691850023
04714691850283047146918502834714691850283

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
833 701 5245chasew@surgicalesthetics.com

Regulatory Flags#

DUNS number
657266016
Device count
10
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

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Primary DI, Brand, Company table
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00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
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00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
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00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31