POPE VENT TUBE

GUDID 00844505008525

POPE BEVEL GROMMET VENT TUBE 1.14mm ID POLYETHYLENE, 30 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505008525
• NIH Device Record Key: ec2d0824-8bdd-42db-94fb-f426c6a07543
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POPE VENT TUBE
• Version Model Number: 530-003
• 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
• 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	00844505008525 [Primary]
GS1	10844505008522 [Package]; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830228

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: 2019-08-14
• Device Publish Date: 2016-02-18

On-Brand Devices [POPE VENT TUBE]

• 00844505008525: POPE BEVEL GROMMET VENT TUBE 1.14mm ID POLYETHYLENE, 30 PACK
• 00844505008518: POPE BEVEL GROMMET VENT TUBE 1.14mm ID POLYETHYLENE 5 PACK
• 00844505004282: POPE VENT TUBE 1.14MM ID SILICONE PAIR 10 PACK
• 00844505004275: POPE VENT TUBE 1.14MM ID SILICONE 5 PACK
• 00844505003186: POPE VENT TUBE 1.14MM ID PC SILICONE 5 PACK
• 10844505014370: POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 60 PACK
• 10844505014363: POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
• 10844505014356: POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
• 10844505014349: POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK