BOBBIN VENT TUBE

GUDID 00844505004060

BOBBIN VENT TUBE 1.02MM ID BLUE FLUOROPLASTIC 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505004060
• NIH Device Record Key: f2d1abf0-b38a-4ae9-b72a-9716324fccff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOBBIN VENT TUBE
• Version Model Number: 525-021
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505004060 [Primary]
GS1	10844505004067 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062385

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: 4
• Public Version Date: 2019-08-13
• Device Publish Date: 2016-02-18

On-Brand Devices [BOBBIN VENT TUBE]

• 00844505008402: BOBBIN VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
• 00844505008020: BOBBIN VENT TUBE 1.02MM ID - FLUOROPLASTIC PAIR 60 PACK
• 00844505007986: BOBBIN VENT TUBE 1.14MM ID - FLUOROPLASTIC 30 PACK
• 00844505007634: BOBBIN VENT TUBE 1.27MM ID - BLUE TITANIUM PAIR 60 PACK
• 00844505004077: BOBBIN VENT TUBE 1.02MM ID BLUE FLUOROPLASTIC 10 PACK
• 00844505004060: BOBBIN VENT TUBE 1.02MM ID BLUE FLUOROPLASTIC 5 PACK
• 00844505004039: BOBBIN VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
• 00844505004022: BOBBIN VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 00844505003674: BOBBIN VENT TUBE 1.02MM ID FLUOROPLASTIC PAIR 10 PACK
• 00844505003667: BOBBIN VENT TUBE 1.02MM ID FLUOROPLASTIC 5 PACK
• 00844505003636: BOBBIN VENT TUBE 1.14MM ID FLUOROPLASTIC PAIR 10 PACK
• 00844505003629: BOBBIN VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
• 00844505002479: BOBBIN VENT TUBE 1.27MM ID BLUE TITANIUM PAIR 10 PACK
• 00844505002455: BOBBIN VENT TUBE 1.27MM ID BLUE TITANIUM 5 PACK
• 00844505002431: BOBBIN VENT TUBE 1.14MM ID BLUE TITANIUM PAIR 10 PACK
• 00844505002417: BOBBIN VENT TUBE 1.14MM ID BLUE TITANIUM 5 PACK
• 00844505002400: BOBBIN VENT TUBE 1.02MM ID BLUE TITANIUM PAIR 10 PACK
• 00844505002394: BOBBIN VENT TUBE 1.02MM ID BLUE TITANIUM 5 PACK