AccessGUDID - DEVICE: Hayrake-Palatal with Spurs (00889989083545)

GUDID

Device Identifier (DI) Information

Brand Name: Hayrake-Palatal with Spurs
Version or Model: 3000-0073
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALLESEE AOA-PRO

Primary DI Number: 00889989083545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 158312728 *Terms of Use

Device Description: Hayrake-Palatal with Spurs

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84c9a7e1-1bf4-4219-a15d-4d6c4d1d4a52
Public Version Date: March 21, 2023
Public Version Number: 1
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +12628861050
Email: more.information@aoalab.com

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