Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules

Basic Information

• Brand Name: Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
• Primary DI: D00265628611
• Version / Model: 656-2861
• Catalog Number: 656-2861
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a7a1823c-fd1e-4059-be33-63280b59d6a8

Device Description

Dispersed Phase Alloy, Fast Set, 1 Spill, 500 (400mg) Green caps

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: Yes
• 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
EJJ	Alloy, amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34837	Transabdominal amnioscope	An endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted into the body through an artificial orifice created by an incision made in the maternal abdominal wall through to the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D00265628612	HIBCC	Case	10	In Commercial Distribution
Primary	D00265628611	HIBCC
Unit of Use	D00265628610	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	400	Milligram
Device Size Text, specify			Fast Set, 1 Spill, 10 cartons of 50 (400mg) Green caps

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.