AccessGUDID - DEVICE: InoMesh (MDLXMAG115100)

GUDID

Device Identifier (DI) Information

Brand Name: InoMesh
Version or Model: MAG1-1510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAG1-1510
Company Name: MEDLINX ACACIA PTE. LTD.

Primary DI Number: MDLXMAG115100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 937305795 *Terms of Use

Device Description: MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate

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?
60300	Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable	An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: ab5d26ba-f6e8-4c62-93b6-f0fe29a017c2
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: December 28, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
MDLXMAG115103	12	MDLXMAG115100	In Commercial Distribution
MDLXMAG115102	6	MDLXMAG115100	In Commercial Distribution
MDLXMAG115101	3	MDLXMAG115100	In Commercial Distribution