SIMON/HANNAH BOBBIN VENT TUBE

GUDID 00844505002585

SIMON/HANNAH BOBBIN VENT TUBE 1.14MM ID GOLD TITANIUM 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505002585
• NIH Device Record Key: 7179bf4e-9cd5-4510-92f0-8cbb003beb34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMON/HANNAH BOBBIN VENT TUBE
• Version Model Number: 500-081
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00844505002585 [Primary]
GS1	10844505002582 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943325

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: 2020-03-13
• Device Publish Date: 2016-02-18

On-Brand Devices [SIMON/HANNAH BOBBIN VENT TUBE]

• 00844505002592: SIMON/HANNAH BOBBIN VENT TUBE 1.14MM ID GOLD TITANIUM PAIR 10 PACK
• 00844505002585: SIMON/HANNAH BOBBIN VENT TUBE 1.14MM ID GOLD TITANIUM 5 PACK