FDA.reportPublic FDA data

LIQUIFIX FIX8

Primary DI
05036912001427
Brand
LIQUIFIX FIX8
Company
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
Model
72014032
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
236059171
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
false
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
05036912001595INTEGUSEAL337362024-11-26
05036912001625INTEGUSEAL337372024-11-26
05036912001410LIQUIFIX FIX8720140322023-06-23
05036912001441LIQUIFIX Precision Open720140332023-06-23
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
05036912001410LIQUIFIX FIX8ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23
05036912001441LIQUIFIX Precision OpenADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23
05036912001458LIQUIFIX Precision OpenADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDPLJ2023-06-23