AccessGUDID - DEVICE: RING-LOK (05051693307865)

GUDID

Device Identifier (DI) Information

Brand Name: RING-LOK
Version or Model: Modular Bi-Polar (60mm- 28mm Head)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP2396
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693307865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Modular Bi-Polar 60mm Dia. (28mm Head) For Uncemented Applications

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?
33175	Metallic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132539	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
Outer Diameter: 60 Millimeter

Device Record Status

Public Device Record Key: c0cb8d1a-15ed-4d10-9f1e-c099b097a581
Public Version Date: April 08, 2024
Public Version Number: 4
DI Record Publish Date: July 31, 2016