AccessGUDID - DEVICE: TIGR® Matrix Surgical Mesh (07332999000093)

GUDID

Device Identifier (DI) Information

Brand Name: TIGR® Matrix Surgical Mesh
Version or Model: NSTM1520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NSTM1520
Company Name: Novus Scientific AB

Primary DI Number: 07332999000093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 776732898 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbable	A sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

GMDN Preferred Term Name

GMDN Definition

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

A sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

FDA Product Code

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Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092224	000
K163005	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

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Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Length: 20 Centimeter
Width: 15 Centimeter

Device Record Status

Public Device Record Key: a74ab542-fec4-4d4b-9999-999ce692f423
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015