DEVICE: Ambroise (08720299427730)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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64729 | External lower-limb prosthesis custom-assembly |
A customized assembly of externally-applied prosthetic devices intended to replace, in part or total, one or more segment(s) and/or joint(s) of the lower limb after amputation (at any hip, knee, or ankle-foot level). The device is assembled and adjusted at the clinic for each patient by joining interface, functional, alignment, structural and finishing prosthetic components.
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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
f6e7bc0a-f1bc-4249-ac31-214946e756cf
September 25, 2023
1
September 15, 2023
September 25, 2023
1
September 15, 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