Elements by Hedy Barrier Envelopes

Basic Information

• Brand Name: Elements by Hedy Barrier Envelopes
• Primary DI: D903HEBEH0
• Version / Model: HE-BEH0
• Catalog Number: HE-BEH0
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-18
• Public Version: 2
• Public Version Date: 2020-07-16
• Public Version Status: Update
• Public Device Record Key: 9a7f9cd1-ae93-4026-a5ce-0d8c0b9cf691

Device Description

Dental Barriers sleeves for Phosphor Storage Plate, Size small

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45256	Digital imaging cassette/storage phosphor screen, dental	A combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D903HEBEH0	HIBCC
Package	D903HEBEH01	HIBCC	Box	100	In Commercial Distribution

Customer Contacts

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