Vertical Crib

Basic Information

• Brand Name: Vertical Crib
• Primary DI: 00889989083477
• Version / Model: 3000-0070
• Company Name: ALLESEE AOA-PRO
• Labeler DUNS: 158312728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-13
• Public Version: 1
• Public Version Date: 2023-03-21
• Public Version Status: New
• Public Device Record Key: 7a0dbe60-e055-40c9-9615-c786de9e47d6

Device Description

Vertical Crib

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMY	POSITIONER, TOOTH, PREFORMED	Dental	872.5525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889989083477	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]