OrthoStore- PINA-COLADA

Basic Information

• Brand Name: OrthoStore- PINA-COLADA
• Primary DI: 00843471100080
• Version / Model: 625-700
• Catalog Number: 625-700
• Company Name: YOUNG INNOVATIONS HOLDINGS LLC
• Labeler DUNS: 078739060
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-19
• Public Version: 4
• Public Version Date: 2022-09-27
• Public Version Status: Update
• Public Device Record Key: 7cce2451-1baf-4b2c-a8a9-2ca7360bf7b2

Device Description

PINA-COLADA

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843471100080	GS1

Premarket Submissions

Submission Number	Supplement Number
K940120	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 2.7 Degrees Celsius