AccessGUDID - DEVICE: COREHIP PRIMARY (04046964681325)

GUDID

Device Identifier (DI) Information

Brand Name: COREHIP PRIMARY
Version or Model: NK1211K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NK1211K
Company Name: Aesculap AG

Primary DI Number: 04046964681325
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: COREHIP STD CEMENTED 12/14 SIZE 11

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
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
Device Size Text, specify: Taper Size : 12/14
Device Size Text, specify: Implant Fixation : cemented
Device Size Text, specify: CCD angle (°) : 132
Device Size Text, specify: Figure / Size : Size 11

Device Record Status

Public Device Record Key: bee22e50-f29b-4206-8f00-8878bcb4ede6
Public Version Date: December 24, 2024
Public Version Number: 2
DI Record Publish Date: August 10, 2020