AccessGUDID - DEVICE: Rx Knee PS Cemented Symmetrical Femur (09348215122867)

GUDID

Device Identifier (DI) Information

Brand Name: Rx Knee PS Cemented Symmetrical Femur
Version or Model: 121-25-0301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIGNATURE ORTHOPAEDICS PTY LTD

Primary DI Number: 09348215122867
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 751993028 *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?
67099	Temporary knee prosthesis, non-customized	A prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic agent to the periprosthetic space to treat infection as part of a revision orthopaedic surgery. Also known as a spacer, it may include knee femur and/or tibial components, and is made of metallic and/or polymer materials. Following infection treatment and device explantation, a definitive prosthesis is implanted.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240683	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3e1dec6-26fc-4b54-8197-c9406952acc0
Public Version Date: November 20, 2024
Public Version Number: 1
DI Record Publish Date: November 12, 2024