AccessGUDID - DEVICE: Iconacy i-Hip (M914011030304800)

GUDID

Device Identifier (DI) Information

Brand Name: Iconacy i-Hip
Version or Model: 01-10303-048-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-10303-048-00
Company Name: Iconacy Orthopedic Implants LLC

Primary DI Number: M914011030304800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 032218374 *Terms of Use

Device Description: HXLP LINER, 28MM I.D. X 48MM O.D., 0 DEG., +4MM

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:	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?
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132572	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: 48 Millimeter

Device Record Status

Public Device Record Key: 7de6a68b-89cf-480d-b6ca-0647704844ec
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 06, 2015