REUTER BOBBIN VENT TUBE

GUDID 00844505003988

REUTER BOBBIN VENT TUBE W/FLANGE HOLES 1.14 MM ID FLUOROPLASTIC PAIR 10 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

• Primary Device ID: 00844505003988
• NIH Device Record Key: c1c2759b-8f89-41d9-9e72-5a581fb9bd33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUTER BOBBIN VENT TUBE
• Version Model Number: 520-182
• 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	00844505003988 [Primary]
GS1	10844505003985 [Package]; Package: [10 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: 4
• Public Version Date: 2019-08-13
• Device Publish Date: 2016-02-18

On-Brand Devices [REUTER BOBBIN VENT TUBE]

• 00844505004220: REUTER BOBBIN VENT TUBE 1.00MM ID BLUE FLUOROPLASTIC PAIR 10 PACK
• 00844505004213: REUTER BOBBIN VENT TUBE 1.00MM ID BLUE FLUOROPLASTIC 5 PACK
• 00844505004008: REUTER BOBBIN VENT TUBE W/FLANGE HOLES 1.14 MM ID - FLUOROPLASTIC PAIR 60 PACK
• 00844505003988: REUTER BOBBIN VENT TUBE W/FLANGE HOLES 1.14 MM ID FLUOROPLASTIC PAIR 10 PACK
• 00844505003971: REUTER BOBBIN VENT TUBE W/FLANGE HOLES 1.14 MM ID FLUOROPLASTIC 5 PACK
• 00844505002615: REUTER BOBBIN VENT TUBE WITH FLANGE HOLES 1.14MM ID BLUE TITANIUM 5 PACK