AccessGUDID - DEVICE: U-Motion II PS+ Cup, no-hole (04711605568333)

GUDID

Device Identifier (DI) Information

Brand Name: U-Motion II PS+ Cup, no-hole
Version or Model: 1306-3354
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1306-3354
Company Name: UNITED ORTHOPEDIC CORP.

Primary DI Number: 04711605568333
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, no-hole, Ø54mm

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?
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
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

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132455	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
Device Size Text, specify: Ø54mm

Device Record Status

Public Device Record Key: 8c5b1978-ec55-41bd-9995-75c221db4a48
Public Version Date: August 07, 2018
Public Version Number: 4
DI Record Publish Date: October 24, 2015