AccessGUDID - DEVICE: Endo-Model Saddle Prosthesis (04026575401482)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Model Saddle Prosthesis
Version or Model: 99-8007/13
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99-8007/13
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575401482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Saddle Component,with suture holes

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?
34190	Uncoated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951355	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
No Device Sizes

Device Record Status

Public Device Record Key: d43920b2-8d03-490b-bd64-5dc83eed502b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 01, 2015