DEVICE: DJO Origin Instrument Tray (09348215058098)
Device Identifier (DI) Information
DJO Origin Instrument Tray
112-212-409
In Commercial Distribution
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution
SIGNATURE ORTHOPAEDICS PTY LTD
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K121297 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
186f7948-d7b7-44d6-9a38-cd8cd25a1474
July 08, 2021
4
November 05, 2019
July 08, 2021
4
November 05, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined