AccessGUDID - DEVICE: GORE ENFORM Preperitoneal Biomaterial (00733132644568)

GUDID

Device Identifier (DI) Information

Brand Name: GORE ENFORM Preperitoneal Biomaterial
Version or Model: GBWR0616
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GBWR0616
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132644568
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: ENFORM PREPERITONEAL 6cmX16cm Biomaterial

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?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a 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]. 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
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement
OWZ	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

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
Length: 6 Centimeter
Width: 16 Centimeter

Device Record Status

Public Device Record Key: 9a85f189-42ac-484d-9294-fd6d0b7cda8e
Public Version Date: October 14, 2024
Public Version Number: 7
DI Record Publish Date: September 28, 2018