FDA.reportPublic FDA data

Ax-Surgi Surgical Hemostat

Primary DI
00860012016648
Brand
Ax-Surgi Surgical Hemostat
Company
Advamedica Inc.
Model
SH1006
Device description
Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Published
2024-10-28
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
PODTemporary, Internal Use Hemostatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PODTemporary, Internal Use HemostaticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213198000Ax-Surgi Surgical HemostatAdvamedica, Inc.2023-01-05POD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012016648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012016648008600120166488600120166480860012016648

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
00860012016686MaxioCel Chitosan Wound DressingMX101252026-06-08
00860012016655MaxioCel Chitosan Wound DressingMX05052025-08-27
00860012016662MaxioCel Chitosan Wound DressingMX15152025-08-27
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
10841495149686QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149709QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149723QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149747QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
30841495149680QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149706QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149720QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149744QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149693QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149716QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149730QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149754QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149778QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936028QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936189QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936202QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936226QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936240QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149690QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149713QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149737QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
30841495149758QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149775QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
34026704936022QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936186QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
34026704936206QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936223QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936247QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149655QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-06
30841495149659QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-06