FDA.reportPublic FDA data

MaxioCel Chitosan Wound Dressing

Primary DI
00860012016679
Brand
MaxioCel Chitosan Wound Dressing
Company
Advamedica Inc.
Model
MX2030
Device description
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: • Pressure sores • Diabetic ulcers • Leg ulcers • Donor sites and graft sites • Surgical wounds • Skin abrasions and lacerations • 1st and 2nd degree bums • Trauma wounds. The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K212766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212766000Maxiocel Chitosan Wound DressingAdvamedica, Inc.2023-08-24KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012016679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012016679008600120166798600120166790860012016679

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Regulatory Flags#

DUNS number
118526617
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850086458062MaxioCel Chitosan Wound DressingMX45452026-08-21
00860012016686MaxioCel Chitosan Wound DressingMX101252026-06-08
00860012016655MaxioCel Chitosan Wound DressingMX05052025-08-27
00860012016662MaxioCel Chitosan Wound DressingMX15152025-08-27
00860012016648Ax-Surgi Surgical Hemostat SH10062024-10-28
00860008768681Axiostat Patch L882024-10-04
00860012016624Ax-Surgi Surgical Hemostat SH10012024-08-07
00860012016631Ax-Surgi Surgical Hemostat SH10042024-08-07
00860008768698MaxioCel Chitosan Wound DressingMX25302024-05-21
00860012016600MaxioCel Chitosan Wound DressingMX05102024-05-21
00860012016617MaxioCel Chitosan Wound DressingMX10102024-05-21
00860008768605Axiostat Patch V552023-12-16
00860008768612Axiostat GauzeAG3002023-12-16
00860008768629Axiostat Patch V352023-12-16
00860008768636Axiostat GauzeAG1502023-12-16
00860008768650Axiostat GauzeAG10102023-12-16
00860008768674Axiostat GauzeAG40102023-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08