Axiostat Patch

Primary DI
00860008768605
Brand
Axiostat Patch
Company
Advamedica Inc.
Model
V55
Device description
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
Published
2023-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202830000Axiostat PatchAdvamedica, Inc.2021-04-15QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008768605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008768605008600087686058600087686050860008768605

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professionalA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118526617
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00860008768612Axiostat GauzeAG3002023-12-16
00860008768629Axiostat Patch V352023-12-16
00860008768636Axiostat GauzeAG1502023-12-16
00860008768650Axiostat GauzeAG10102023-12-16
00860008768674Axiostat GauzeAG40102023-12-16

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