AccessGUDID - DEVICE: Klassic HD Acetabular Cup with Ti-Coat (00814703014963)

GUDID

Device Identifier (DI) Information

Brand Name: Klassic HD Acetabular Cup with Ti-Coat
Version or Model: 3400.44.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00814703014963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Acetabular Cup with Ti-Coat, size 44mm

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?
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180929	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 44mm

Device Record Status

Public Device Record Key: e372e2ea-b2bb-45fa-991c-5904f8e661bb
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: June 12, 2018