AccessGUDID - DEVICE: iUni® iPoly™ Insert Kit (M572RUK0101000021)

GUDID

Device Identifier (DI) Information

Brand Name: iUni® iPoly™ Insert Kit
Version or Model: RUK010100002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RUK0101000
Company Name: Conformis, Inc.

Primary DI Number: M572RUK0101000021
Issuing Agency: HIBCC
Commercial Distribution End Date:
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 [?]
K132640	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: 10 Millimeter

Device Record Status

Public Device Record Key: 52618b61-d069-4c78-b476-223b35199eb5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 26, 2015