Hummingbird Tympanostomy Tube System 05-1001-653

GUDID 50853386007072

05-1001-653, +90 Inserter With Pre-loaded Vent Tube

PRECEPTIS 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

• Primary Device ID: 50853386007072
• NIH Device Record Key: c1361dd3-3afb-433a-8d98-e1081b7c3cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hummingbird Tympanostomy Tube System
• Version Model Number: 05-1001-653
• Catalog Number: 05-1001-653
• Company DUNS: 011948777
• Company Name: PRECEPTIS MEDICAL, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853386007077 [Primary]
GS1	50853386007072 [Package]; Contains: 00853386007077; Package: 10 Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142282

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Hummingbird Tympanostomy Tube System]

• 00853386007046: 05-1001-503, -90/-90 Inserter Assembly With Pre-loaded Vent Tube
• 00853386007053: 05-1001-502, +90/+90 Inserter Assembly With Pre-loaded Vent Tube
• 00853386007015: 05-1001-501, +90/-90 Inserter Assembly With Pre-loaded Vent Tube
• 50853386007072: 05-1001-653, +90 Inserter With Pre-loaded Vent Tube
• 50853386007065: 05-1001-652, -90 Inserter With Pre-loaded Vent Tube