AccessGUDID - DEVICE: Implant Partners (M684PRTLS032WD1)

GUDID

Device Identifier (DI) Information

Brand Name: Implant Partners
Version or Model: PRTLS030WD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRTLS032WD
Company Name: Microport Orthopedics Inc.

Primary DI Number: M684PRTLS032WD1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079118736 *Terms of Use

Device Description: TL PLASMA STR SHORT SIZE 12 IMPLANT PARTNERS™

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?
55834	Press-fit hip femur prosthesis, one-piece	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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
No Device Sizes

Device Record Status

Public Device Record Key: e516c65e-cfd1-4db5-ad8a-5634360eb323
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 23, 2015