FDA.reportPublic FDA data

VeraFill Dental Collagen Wound Dressing

Primary DI
04714691213934
Brand
VeraFill Dental Collagen Wound Dressing
Company
MAXIGEN BIOTECH INC.
Model
HAD001020
Published
2025-11-04
Public version status
New
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
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLROral Wound DressingUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04714691213934PrimaryGS10
04714691213927Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04714691213934047146912139344714691213934
04714691213927047146912139274714691213927

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
657266016
Device count
10
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
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2026-03-30
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
00860013569907MuGardSoleva Pharma LLCOLR2025-02-28
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213521HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213606Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213590Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850467Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213132Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213170Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213477HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213484HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691850283HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691850290HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213460HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-22
10686864060779MedicomAMD Medicom IncOLR2024-05-08
20686864060776MedicomAMD Medicom IncOLR2024-05-08