AccessGUDID - DEVICE: MP Reconstruction Prosthesis (04026575203062)

GUDID

Device Identifier (DI) Information

Brand Name: MP Reconstruction Prosthesis
Version or Model: 172-950/10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 172-950/10
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575203062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Proximal Spacer

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?
61560	Sleeve femoral/tibial extension, uncoated	A sterile implantable device typically designed to be attached to a revision femoral stem prosthesis, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to compensate for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142187	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: Length=10mm

Device Record Status

Public Device Record Key: 4297f82b-4644-44e2-98d3-9b8133ee34bc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 01, 2015