PAPARELLA VENT TUBE

GUDID 00844505007955

PAPARELLA VENT TUBE 1.14MM ID - SILICONE PAIR 60 PACK

Grace Medical, Inc.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 00844505007955
• NIH Device Record Key: 03287f52-5358-45a8-9b43-923780f60619
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAPARELLA VENT TUBE
• Version Model Number: 510-326
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505007955 [Primary]
GS1	10844505007952 [Package]; Package: [60 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: 4
• Public Version Date: 2019-08-13
• Device Publish Date: 2016-02-18

On-Brand Devices [PAPARELLA VENT TUBE]

• 00844505008570: PAPARELLA VENT TUBE W/ TAB 1.14MM ID - SILICONE PAIR 60 PACK
• 00844505007955: PAPARELLA VENT TUBE 1.14MM ID - SILICONE PAIR 60 PACK
• 00844505007948: PAPARELLA VENT TUBE 1.14MM ID - SILICONE 30 PACK
• 00844505007924: PAPARELLA VENT TUBE 1.14MM ID SILICONE 5 PACK
• 00844505007887: PAPARELLA VENT TUBE W/ TAB 1.14MM ID SILICONE 30 PACK
• 00844505007795: PAPARELLA VENT TUBE W/ TAB 1.27MM ID - SILICONE 50 PACK
• 00844505003391: PAPARELLA VENT TUBE 1.27MM ID PC SILICONE PAIR 10 PACK
• 00844505003384: PAPARELLA VENT TUBE 1.27MM ID PC SILICONE 5 PACK
• 00844505002912: PAPARELLA VENT TUBE W/ TAB 1.14MM ID PC SILICONE 5 PACK
• 00844505002882: PAPARELLA VENT TUBE 1.02MM ID - PC SILICONE 30 PACK
• 00844505002851: PAPARELLA VENT TUBE 1.02MM ID PC SILICONE 5 PACK
• 00844505002820: PAPARELLA VENT TUBE W/ TAB 1.02MM ID - SILICONE 50 PACK
• 00844505002813: PAPARELLA VENT TUBE W/ TAB 1.02MM ID - PC SILICONE 30 PACK
• 00844505002790: PAPARELLA VENT TUBE W/ TAB 1.02MM ID PC SILICONE PAIR 10 PACK
• 00844505002776: PAPARELLA VENT TUBE W/ TAB 1.02MM ID PC SILICONE 5 PACK