DEVICE: Lightning X Products,Inc (06974567745749)
Device Identifier (DI) Information
Lightning X Products,Inc
LXRS-KIT-PRO
In Commercial Distribution
Wuxi Emsrun Technology Co., Ltd.
LXRS-KIT-PRO
In Commercial Distribution
Wuxi Emsrun Technology Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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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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64881 | First aid limb splint, mouldable, single-use |
A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, or a thermoplastic material designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ILH | Splint, Hand, And Components |
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
4dbe4754-1dfa-4cc4-a46c-49f5f9498405
December 15, 2022
1
December 07, 2022
December 15, 2022
1
December 07, 2022
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