AccessGUDID - DEVICE: Stability (05051693300729)

GUDID

Device Identifier (DI) Information

Brand Name: Stability
Version or Model: Flanged Uncemented Hip Stem - Size 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HS1315
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693300729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Flanged Uncemented Hip Stem - Size 4 - 167mm long (Cobalt Chrome) 12/14 Taper

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
33581	Coated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) 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 coated with a material (e.g., porous materials, hydroxyapatite) 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 may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922613	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
Special Storage Condition, Specify: Room temperature and Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 167 Millimeter

Device Record Status

Public Device Record Key: 6abaefcd-ce42-486a-b349-6b5269828a9e
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: July 31, 2016