AccessGUDID - DEVICE: United Hip System, U-Motion II PS Cup,Multi-Hole (04712771503401)

GUDID

Device Identifier (DI) Information

Brand Name: United Hip System, U-Motion II PS Cup,Multi-Hole
Version or Model: 1306-3480
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1306-3480
Company Name: UNITED ORTHOPEDIC CORP.

Primary DI Number: 04712771503401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656700556 *Terms of Use

Device Description: U-Motion II PS Cup, multi-hole, Ø80mm

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?
33715	Ceramic-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true
34204	Ceramic-on-ceramic total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-ceramic interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172833	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: 80 Millimeter

Device Record Status

Public Device Record Key: 38fddef0-f5a3-4b4d-b2de-f4c53ab1eff3
Public Version Date: August 07, 2018
Public Version Number: 5
DI Record Publish Date: October 24, 2015