Original D Capsules 3 Spill Fast Set 500 count

Basic Information

• Brand Name: Original D Capsules 3 Spill Fast Set 500 count
• Primary DI: 00853383006240
• Version / Model: 61342-03
• Company Name: Wykle Research, Inc
• Labeler DUNS: 614557155
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 92c664c5-d25e-4f8a-87a8-f06e868bb65f

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: 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
OIV	Dental Amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16367	Dental amalgam	A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853383006240	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 28 Degrees Celsius