DEVICE: LITe BIO Delivery System (07613327175776)
Device Identifier (DI) Information
LITe BIO Delivery System
48288211
In Commercial Distribution
48288211
Stryker Corporation
48288211
In Commercial Distribution
48288211
Stryker Corporation
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Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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Yes | |
No | |
No | |
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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? |
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45253 | Orthopaedic cement preparation/delivery kit |
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
7c78b3b5-2da8-4d53-8c49-08037d0da27d
October 15, 2019
3
August 15, 2016
October 15, 2019
3
August 15, 2016
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