FRIGI-DENT EFD140A

GUDID 00841494103224

FRIGI-DENT, 280-GRM CANISTER W STRAWS

Ellman International

Cryogenic spray, dental

• Primary Device ID: 00841494103224
• NIH Device Record Key: 4cc691b5-4a66-4028-9b60-7286288f72bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRIGI-DENT
• Version Model Number: EFD140A
• Catalog Number: EFD140A
• Company DUNS: 079095245
• Company Name: Ellman International
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494103224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954703

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [FRIGI-DENT]

• 00841494103224: FRIGI-DENT, 280-GRM CANISTER W STRAWS
• 10841494105133: FRIGI-DENT - CASE OF 25 CANS AND STRAWS