Save-A-Tooth

Basic Information

• Brand Name: Save-A-Tooth
• Primary DI: 00854498007986
• Version / Model: SAT2411
• Catalog Number: SAT2411
• Company Name: Smarthealth, Inc.
• Labeler DUNS: 061081477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-03
• Public Version: 1
• Public Version Date: 2023-04-11
• Public Version Status: New
• Public Device Record Key: 1c4ccb43-5a89-49b3-815e-48394efeae63

Device Description

Cell culture to sustain viability of knocked out tooth for implantation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJF	System, Suspension, Cell Culture	Hematology	864.2240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854498007986	GS1
Package	10854498007983	GS1	Carton	27	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit