DEVICE: Klassic HD Hip Case 3, Acetabular Reamer and Miscellaneous Instruments, AL (00819251021944)
Device Identifier (DI) Information
Klassic HD Hip Case 3, Acetabular Reamer and Miscellaneous Instruments, AL
1407.00.000
In Commercial Distribution
TOTAL JOINT ORTHOPEDICS, INC.
1407.00.000
In Commercial Distribution
TOTAL JOINT ORTHOPEDICS, INC.
Hip Case 3, Acetabular Reamer and Miscellaneous Instruments, AL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12143 | Instrument tray, reusable |
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OJH | Orthopedic tray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c4326578-3d9a-416b-aed5-dd4023444c11
December 12, 2023
6
October 23, 2019
December 12, 2023
6
October 23, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(801)486-6070
udi@tjoinc.com
udi@tjoinc.com