Axiostat Patch

Primary DI
00860008768681
Brand
Axiostat Patch
Company
Advamedica Inc.
Model
L88
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
2024-10-04
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
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

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
00860008768681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008768681008600087686818600087686810860008768681

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012016655MaxioCel Chitosan Wound DressingMX05052025-08-27
00860012016662MaxioCel Chitosan Wound DressingMX15152025-08-27
00860012016648Ax-Surgi Surgical Hemostat SH10062024-10-28
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
00860007891168TRAUMAGEL®Cresilon, Inc.QSY2026-06-01
00017276241709Rapid SealAso LLCQSY2026-05-27
10841495149679QUIKCLOTTELEFLEX INCORPORATEDQSY2026-05-11
00050428142530CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDQSY2026-04-23
10841495149648QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
14026704935892QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
00834061005236StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005243StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005250StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005267StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005274StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005281StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005298StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005304StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005366StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005373StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
10841495150385QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150408QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150422QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150446QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930088QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930101QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930149QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930163QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150389QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150402QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150426QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150440QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930082QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930105QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20