Invotec Tympanostomy Tube 23-40120

GUDID 10818501020307

Invotec Tympanostomy Tube, Shepard Grommet, ID 1.02mm, FLPL

INVOTEC INTERNATIONAL, INC.

Tympanostomy tube

• Primary Device ID: 10818501020307
• NIH Device Record Key: 949ab5c2-f87f-4980-8014-4ab49efe368c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invotec Tympanostomy Tube
• Version Model Number: 1
• Catalog Number: 23-40120
• Company DUNS: 622812592
• Company Name: INVOTEC INTERNATIONAL, INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818501020300 [Primary]
GS1	10818501020307 [Package]; Contains: 00818501020300; Package: 10 [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903285

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: 2017-01-03

On-Brand Devices [Invotec Tympanostomy Tube]

• 10818501020710: Invotec Tympanostomy Tube, Reuter Bobbin w/Wire, 1.14mm, Titanium
• 10818501020741: Invotec Tympanostomy Tube, Collar Button w/Wire, 1.5mm, Gold Plated
• 10818501020734: Invotec Tympanostomy Tube, Collar Button w/Wire, 1.25mm, Gold Plated
• 10818501020703: Invotec Tympanostomy Tube, Reuter Bobbin, 1.14mm, FLPL Blue
• 10818501020697: Invotec Tympanostomy Tube, Sheehy Collar Button, 1.27mm, FLPL Blue
• 10818501020659: Invotec Tympanostomy Tube, Reuter Bobbin w/Wire, 1.10mm, Titanium
• 10818501020642: Invotec Tympanostomy Tube, Spoon Bobbin, 1.14mm, Titanium
• 10818501020635: Invotec Tympanostomy Tube, Reuter Bobbin, 1.14mm, Titanium
• 10818501020628: Invotec Tympanostomy Tube, Reuter Bobbin, 1.27mm, Titanium
• 10818501020611: Invotec Tympanostomy Tube, Ultra Vent, 1.27mm, Silicone
• 10818501020604: Invotec Tympanostomy Tube, Armstrong Straight Shank, 1.14mm, Silicone
• 10818501020598: Invotec Tympanostomy Tube, Armstrong Grommet, 1.14mm, Silicone
• 10818501020581: Invotec Tympanostomy Tube, Paparella II, 1.50mm, Silicone
• 10818501020567: Invotec Tympanostomy Tube, Paparella I, 1.00mm, Silicone
• 10818501020574: Invotec Tympanostomy Tube, Paparella I, 1.14mm, Silicone
• 10818501020550: Invotec Tympanostomy Tube, T-Grommet, 1.14mm, Silicone
• 10818501020543: Invotec Tympanostomy Tube, Modified T-Tube, 1.32mm, Silicone
• 10818501020536: Invotec Tympanostomy Tube, T-Tube, 1.14mm, Silicone
• 10818501020529: Invotec Tympanostomy Tube, Shea Parasol, 1.02mm, Silicone
• 10818501020512: Invotec Tympanostomy Tube, Collar Button, Silicone
• 10818501020505: Invotec Tympanostomy Tube, Donaldson w/o Tab, Silicone
• 10818501020499: Invotec Tympanostomy Tube, Donaldson w/Tab, Silicone
• 10818501020482: Invotec Tympanostomy Tube, Pope Beveled Button,1.14mm, PE
• 10818501020475: Invotec Tympanostomy Tube, Tiny Tef,0.76mm, FLPL
• 10818501020468: Invotec Tympanostomy Tube, Beveled Button,1.14mm, FLPL
• 10818501020451: Invotec Tympanostomy Tube, Baxter Button,1.27mm, FLPL
• 10818501020444: Invotec Tympanostomy Tube, Straight Shank Ventilation Tube, 0.089mm x 7.0mm, FLPL
• 10818501020437: Invotec Tympanostomy Tube, Straight Shank Ventilation Tube,1.14mm x 7.0mm, FLPL
• 10818501020420: Invotec Tympanostomy Tube, Straight Shank Ventilation Tube, 1.14mm x 12.0mm, FLPL
• 10818501020413: Invotec Tympanostomy Tube, Straight Shank Ventilation Tube, 0.089mm x 12.0mm, FLPL
• 10818501020406: Invotec Tympanostomy Tube, Modified Armstrong Grommet, FLPL
• 10818501020390: Invotec Tympanostomy Tube, Shah Grommet w/Wire, ID 1.14mm, FLPL
• 10818501020383: Invotec Tympanostomy Tube, Shah Grommet, ID 1.14mm, FLPL
• 10818501020376: Invotec Tympanostomy Tube, Reuter Bobbin w/Wire, ID 1.14mm, FLPL
• 10818501020369: Invotec Tympanostomy Tube, Reuter Bobbin, ID 1.14mm, FLPL
• 10818501020352: Invotec Tympanostomy Tube, Sheehy Grommet w/Wire, ID 1.27mm, FLPL
• 10818501020345: Invotec Tympanostomy Tube, Sheehy Grommet, ID 1.27mm, FLPL
• 10818501020338: Invotec Tympanostomy Tube, Donaldson Grommet w/Wire, ID 1.14mm, FLPL
• 10818501020321: Invotec Tympanostomy Tube, Donaldson Grommet, ID 1.14mm, FLPL
• 10818501020314: Invotec Tympanostomy Tube, Shepard Grommet w/Wire, ID 1.02mm, FLPL
• 10818501020307: Invotec Tympanostomy Tube, Shepard Grommet, ID 1.02mm, FLPL
• 10818501020291: Invotec Tympanostomy Tube, Shepard Grommet w/Wire, ID 1.14mm, FLPL
• 10818501020284: Invotec Tympanostomy Tube, Shepard Grommet w/Wire, ID 1.14mm, FLPL Blue
• 10818501020277: Invotec Tympanostomy Tube, Shepard Grommet, ID 1.14mm, FLPL Blue
• 10818501020260: Invotec Tympanostomy Tube, Shepard Grommet, ID 1.14mm, FLPL
• 10818501020253: Invotec Tympanostomy Tube, Collar Button, 1.50mm w/Wire, Titanium
• 10818501020246: Invotec Tympanostomy Tube, Collar Button, 1.27mm w/Wire, Titanium
• 10818501020239: Invotec Tympanostomy Tube, Shepard Grommet, 1.27mm w/Wire, Titanium
• 10818501020222: Invotec Tympanostomy Tube, Shepard Grommet, 1.00mm w/Wire, Titanium
• 10818501020215: Invotec Tympanostomy Tube, Collar Button, 1.00mm w/Wire, Titanium