AccessGUDID - DEVICE: Parietene DS (10884521795419)

GUDID

Device Identifier (DI) Information

Brand Name: Parietene DS
Version or Model: PPDS2520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SOFRADIM PRODUCTION

Primary DI Number: 10884521795419
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 576342646 *Terms of Use

Device Description: Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking

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?
44756	Extra-gynaecological surgical mesh, composite-polymer	A partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. 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 [?]
K163212	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
Length: 20 Centimeter
Width: 25 Centimeter

Device Record Status

Public Device Record Key: ffbe7fe6-f200-464e-93e1-b270de00749a
Public Version Date: March 17, 2023
Public Version Number: 5
DI Record Publish Date: January 26, 2020