DEVICE: Hayrake-Palatal with Spurs (00889989083545)

Device Identifier (DI) Information

Hayrake-Palatal with Spurs
3000-0073
In Commercial Distribution

ALLESEE AOA-PRO
00889989083545
GS1

1
158312728 *Terms of Use
Hayrake-Palatal with Spurs
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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
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FDA Product Code

[?]
Product Code Product Code Name
KMY POSITIONER, TOOTH, PREFORMED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

84c9a7e1-1bf4-4219-a15d-4d6c4d1d4a52
March 21, 2023
1
March 13, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+12628861050
more.information@aoalab.com
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