DEVICE: Elbow Immobilizer (D867ELILG0)
Device Identifier (DI) Information
Elbow Immobilizer
ELILG
In Commercial Distribution
ELILG
Xemax Surgical Products Inc
ELILG
In Commercial Distribution
ELILG
Xemax Surgical Products Inc
Elbow immobilizer with Velcro straps.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
12096 | Elbow immobilizer |
A non-rigid external device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IQI | Orthosis, Limb Brace |
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
e3463447-6b09-49b6-b3d1-f223fd6097ed
July 25, 2024
2
June 12, 2023
July 25, 2024
2
June 12, 2023
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