Primary Device ID | B0462204032500 |
NIH Device Record Key | bf638039-602c-42e7-add6-44df3313f472 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Patellar Button |
Version Model Number | 32/50 |
Catalog Number | 22-04-03250 |
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 |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com | |
Phone | 8103647070 |
vfowler@signalmd.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B0462204032500 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-08 |
Device Publish Date | 2019-09-30 |
B0462204034550 | Patellar Button 34/55 |
B0462204032500 | Patellar Button 32/50 |
B0462204030450 | Patellar Button 30/45 |
B0462204028400 | Patellar Button 28/40 |