AccessGUDID - DEVICE: Freedom - ProFlor Inguinal Hernia Implant (00850012832010)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom - ProFlor Inguinal Hernia Implant
Version or Model: FIHR 25mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FIHR 25mm
Company Name: INSIGHTRA MEDICAL, INC.

Primary DI Number: 00850012832010
Issuing Agency: GS1
Commercial Distribution End Date:
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, sold separately, 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: 1af5f14e-9f12-48a8-96fc-ba7299d912dc
Public Version Date: June 10, 2022
Public Version Number: 9
DI Record Publish Date: July 22, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00013964672374	6	00850012832010	2020-07-14	Not in Commercial Distribution	Shipper Box Implant
00850012832027	6	00850012832010		In Commercial Distribution	Shipper Box Implant