AccessGUDID - DEVICE: iDuo® iPoly™ Insert Kit (M572RBK0100600011)

GUDID

Device Identifier (DI) Information

Brand Name: iDuo® iPoly™ Insert Kit
Version or Model: RBK010060001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RBK0100600
Company Name: Conformis, Inc.

Primary DI Number: M572RBK0100600011
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?	MR Conditional
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
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OOG	Knee Arthroplasty Implantation System

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
Height: 6 Millimeter

Device Record Status

Public Device Record Key: 1519fa2b-96e8-4c4c-9dbb-da05cd5aed56
Public Version Date: August 16, 2022
Public Version Number: 3
DI Record Publish Date: October 26, 2015