AccessGUDID - DEVICE: LIQUIFIX FIX8 (05036912001410)

GUDID

Device Identifier (DI) Information

Brand Name: LIQUIFIX FIX8
Version or Model: 72014032
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED

Primary DI Number: 05036912001410
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 236059171 *Terms of Use

Device Description: LIQUIFIX FIX8, non-penetrating hernia mesh fixation, 40+ liquid anchors

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58777	Surgical internal adhesive/sealant, synthetic polymer	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLJ	Tissue Adhesive Internal Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220024	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b1a83cf-da59-41ce-a089-009aeaaeced4
Public Version Date: December 03, 2024
Public Version Number: 2
DI Record Publish Date: June 23, 2023