Patellar Button 22-04-03455

GUDID B0462204034550

Polyethylene patella prosthesis

Primary Device ID	B0462204034550
NIH Device Record Key	ed1c8280-af39-46bf-b68d-895ad09bdeaf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Patellar Button
Version Model Number	34/55
Catalog Number	22-04-03455
Company DUNS	169289308
Company Name	SIGNAL MEDICAL CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B0462204034550 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true