AccessGUDID - DEVICE: iUni® iPoly™ Insert Kit (M572RUK0100800011)

GUDID

Device Identifier (DI) Information

Brand Name: iUni® iPoly™ Insert Kit
Version or Model: RUK010080001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RUK0100800
Company Name: Conformis, Inc.

Primary DI Number: M572RUK0100800011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: N/A

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:	Yes
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?
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
OOG	Knee Arthroplasty Implantation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072586	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
Height: 8 Millimeter

Device Record Status

Public Device Record Key: 1a9c7b59-20e7-4375-8aa0-80debca29f38
Public Version Date: August 16, 2022
Public Version Number: 4
DI Record Publish Date: October 26, 2015