TRIUNE VENT TUBE

GUDID 00844505007962

TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH SILICONE, 80 DUROMETER 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505007962
• NIH Device Record Key: 6b53aa37-990d-4655-8fdd-bb949a1ea73d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIUNE VENT TUBE
• Version Model Number: 510-331
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505007962 [Primary]
GS1	10844505007969 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981575

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-30
• Device Publish Date: 2016-02-18

On-Brand Devices [TRIUNE VENT TUBE]

• 00844505007962: TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH SILICONE, 80 DUROMETER 5 PACK
• 00844505007818: TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH - SILICONE 30 PACK
• 00844505003070: TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH SILICONE PAIR 10 PACK
• 00844505003063: TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH PC SILICONE 5 PACK
• 00844505003056: TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH SILICONE 5 PACK