Primary Device ID | 00814703013577 |
NIH Device Record Key | 7d460a8f-860c-4d62-a95d-97cd0e1286b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic Blade Femoral Stem |
Version Model Number | 3105.12.000 |
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 HD Hip System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814703013577 [Primary] |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814703013577]
Radiation Sterilization
[00814703013577]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-08-31 |
00814703013577 | Blade Femoral Stem, Porous, size 12 |
00814703013560 | Blade Femoral Stem, Porous, size 11 |
00814703013553 | Blade Femoral Stem, Porous, size 10 |