Helo Bite Registration PA003RS

GUDID 00858653006326

Bite Registration - Regular Set - 2/pk

AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

Silicone dental impression material

• Primary Device ID: 00858653006326
• NIH Device Record Key: b431f04a-bc41-4b1f-af2e-35d126068a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helo Bite Registration
• Version Model Number: Regular Set
• Catalog Number: PA003RS
• Company DUNS: 180611519
• Company Name: AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858653006326 [Primary]

FDA Product Code

• ELW: Material, Impression

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: 2018-04-02
• Device Publish Date: 2018-02-28

On-Brand Devices [Helo Bite Registration]

• 00858653006326: Bite Registration - Regular Set - 2/pk
• 00858653006319: Bite Registration - Fast Set - 2/pk