AccessGUDID - DEVICE: Freedom - ProFlor Inguinal Hernia Kit (00837654352878)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom - ProFlor Inguinal Hernia Kit
Version or Model: FIHR 25mmK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FIHR 25mmK
Company Name: INSIGHTRA MEDICAL, INC.

Primary DI Number: 00837654352878
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 097664937 *Terms of Use

Device Description: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.

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":	Yes
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 [?]
K113552	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
Outer Diameter: 25 Millimeter

Device Record Status

Public Device Record Key: 53a5d8a6-19f2-4b2a-8d39-a6b4b1132291
Public Version Date: June 10, 2022
Public Version Number: 7
DI Record Publish Date: July 22, 2015