DEVICE: OrthoGap Archwire Markers (05060772890013)
Device Identifier (DI) Information
OrthoGap Archwire Markers
AX-WOMOG
Not in Commercial Distribution
AX-WOMOG
PHOENIX ORTHODONTICS INC
AX-WOMOG
Not in Commercial Distribution
AX-WOMOG
PHOENIX ORTHODONTICS INC
ORTHOGAP ARCHWIRE MARKERS PK100
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
41397 | Orthodontic archwire |
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZN | INSTRUMENTS, DENTAL HAND |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
3581ca3e-5de0-491a-a344-25f45c688aa0
August 19, 2024
3
August 17, 2020
August 19, 2024
3
August 17, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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:
05060772890068
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(816)2286628
kim@phoenixorthodontics.com
kim@phoenixorthodontics.com