AccessGUDID - DEVICE: implaFit® hip stem with collar cemented lateralized (04048844477455)

GUDID

Device Identifier (DI) Information

Brand Name: implaFit® hip stem with collar cemented lateralized
Version or Model: 80081007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: implantcast GmbH

Primary DI Number: 04048844477455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324369826 *Terms of Use

Device Description: No description.

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?
64708	Coated femoral stem prosthesis, one-piece	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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
Device Size Text, specify: 7

Device Record Status

Public Device Record Key: 9964e168-949e-403f-83c0-c9e17e3abb6d
Public Version Date: August 29, 2022
Public Version Number: 1
DI Record Publish Date: August 20, 2022