AccessGUDID - DEVICE: SURGIMESH®XB (03700296903296)

GUDID

Device Identifier (DI) Information

Brand Name: SURGIMESH®XB
Version or Model: TINTRAOK1522
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TINTRAOK1522
Company Name: ASPIDE MEDICAL

Primary DI Number: 03700296903296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 395941714 *Terms of Use

Device Description: A non woven, non knitted layer reinforcement material made from polypropylene and a silicone layer

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

[?]

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
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Skirted Oval 15x22cm

Device Record Status

Public Device Record Key: e39ee690-8705-4b0b-bd96-f3389c1962f3
Public Version Date: June 10, 2022
Public Version Number: 7
DI Record Publish Date: October 23, 2015