Primary Device ID | 00814703012785 |
NIH Device Record Key | 64af14a4-0dcb-4b02-add1-bc8bbd129b69 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic HD Acetabular Insert with XLPE, 32mm head, size 52mm |
Version Model Number | 3503.52.032 |
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 | 00814703012785 [Primary] |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814703012785]
Ethylene Oxide
[00814703012785]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-25 |
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