DEVICE: Hayrake-Palatal with Spurs (00889989083545)
Device Identifier (DI) Information
Hayrake-Palatal with Spurs
3000-0073
In Commercial Distribution
ALLESEE AOA-PRO
3000-0073
In Commercial Distribution
ALLESEE AOA-PRO
Hayrake-Palatal with Spurs
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? |
---|---|---|---|---|
65675 | Orthodontic habit prevention/breaking appliance, bonded |
An orthodontic device intended to be bonded (fixed) to the teeth of a child to prevent or help break habits (typically finger sucking or tongue thrusting) that adversely affect the position of developing dentition. It is typically in the form of pins, a small sphere, or a circular/discoid structure held in the palate with wires and metal bands. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KMY | POSITIONER, TOOTH, PREFORMED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
84c9a7e1-1bf4-4219-a15d-4d6c4d1d4a52
March 21, 2023
1
March 13, 2023
March 21, 2023
1
March 13, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+12628861050
more.information@aoalab.com
more.information@aoalab.com