Elements by Hedy Barrier Envelopes HE-BEHO1

GUDID D903HEBEHO11

Dental Barrier Sleeves for Phosphor Storage, Size Medium

Hedy Canada

Digital imaging cassette/storage phosphor screen, dental

• Primary Device ID: D903HEBEHO11
• NIH Device Record Key: 1423c391-9460-4309-9dc5-ed82290320f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements by Hedy Barrier Envelopes
• Version Model Number: HE-BEHO1
• Catalog Number: HE-BEHO1
• Company DUNS: 249482399
• Company Name: Hedy Canada
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D903HEBEHO1 [Primary]
HIBCC	D903HEBEHO11 [Package]; Contains: D903HEBEHO1; Package: Box [100 Units]; In Commercial Distribution

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-26
• Device Publish Date: 2019-03-18

On-Brand Devices [Elements by Hedy Barrier Envelopes]

• D903HEBEHO21: Dental Barrier Sleeves for Phosphor Storage Plates, Size Large
• D903HEBEHO11: Dental Barrier Sleeves for Phosphor Storage, Size Medium
• D903HEBEH0: Dental Barriers sleeves for Phosphor Storage Plate, Size small