REUTER BOBBIN VENT TUBE WO WIRE WHOLES TWIN PACK 114MM ID STAINLESS STEEL GLASS

GUDID 00821925039735

Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear while creating an avenue passage for air pressure equalization on either side of the drum.

Gyrus Acmi, 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 Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 00821925039735
• NIH Device Record Key: 74c32035-f354-46a6-9bbf-c6f46ed09b9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUTER BOBBIN VENT TUBE WO WIRE WHOLES TWIN PACK 114MM ID STAINLESS STEEL GLASS
• Version Model Number: 70921873
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 2
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925022904 [Package]; Package: [60 Units]; In Commercial Distribution
GS1	00821925039735 [Primary]
GS1	00821925040755 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820362

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

Devices Manufactured by Gyrus Acmi, Inc.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)