Primary Device ID | 00814703010712 |
NIH Device Record Key | 601d8c23-a1d0-4cd5-8d6f-65bdb1baeab9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic Knee Tibial Baseplate Assembly, Size 4 |
Version Model Number | 5200.04.000 |
Company DUNS | 078416717 |
Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
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 | false |
Manufacturing Date | false |
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 | +1(801)486-6070 |
udi@tjoinc.com | |
Phone | +1(801)486-6070 |
udi@tjoinc.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814703010712 [Primary] |
JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814703010712]
Radiation Sterilization
[00814703010712]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-12-11 |
Device Publish Date | 2015-10-22 |
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