FDA.reportPublic FDA data

LIQUIFIX FIX8

Primary DI
05036912001410
Brand
LIQUIFIX FIX8
Company
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
Model
72014032
Device description
LIQUIFIX FIX8, non-penetrating hernia mesh fixation, 40+ liquid anchors
Published
2023-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLJTissue Adhesive Internal Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLJTissue Adhesive Internal UseGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220024000LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation DeviceAdvanced Medical Solutions Limited2023-06-02PLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05036912001427PackageGS11In Commercial Distribution
05036912001434PackageGS16In Commercial Distribution
05036912001410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05036912001427050369120014275036912001427
05036912001434050369120014345036912001434
05036912001410050369120014105036912001410

GMDN Terms#

Term, Definition table
TermDefinition
Surgical internal adhesive/sealant, synthetic polymerA biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
236059171
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05036912001595INTEGUSEAL337362024-11-26
05036912001625INTEGUSEAL337372024-11-26
05036912001441LIQUIFIX Precision Open720140332023-06-23
05036912001427LIQUIFIX FIX8720140322023-06-23
05036912001458LIQUIFIX Precision Open720140332023-06-23
05036912000758LiquiBand ButylLQB0012023-06-12
05036912001687LiquiBand ExceedLBE0012023-06-12
05036912001717LiquiBand Exceed XSLBEXS0012023-06-12
05036912001748LiquiBand Octyl MiniLBCM0012023-06-12
05036912000406LiquiBand ButylLQB0012023-06-12
05036912001694LiquiBand ExceedLBE0012023-06-12
05036912001724LiquiBand Exceed XSLBEXS0012023-06-12
05036912001755LiquiBand Octyl MiniLBCM0012023-06-12
05036912001502LiquiBand SecureM13222023-05-19
05036912001533LiquiBand SecureM13422023-05-19
05036912001557LiquiBand SecureM13662023-05-19
05036912001519LiquiBand SecureM13222023-05-19
05036912001540LiquiBand SecureM13422023-05-19
05036912001571LiquiBand SecureM13662023-05-19
05036912001656LiquiBand XL72014046A2023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05036912001441LIQUIFIX Precision OpenADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23
05036912001427LIQUIFIX FIX8ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23
05036912001458LIQUIFIX Precision OpenADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23