TubaVent® short 2080-1236320-US

GUDID 04250676743503

Spiggle & Theis Medizintechnik GmbH

Eustachian catheter, single-use

• Primary Device ID: 04250676743503
• NIH Device Record Key: 44687d7d-40d3-4547-ac07-5164ffbe3a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubaVent® short
• Version Model Number: 2080-1236320-US
• Catalog Number: 2080-1236320-US
• Company DUNS: 332893028
• Company Name: Spiggle & Theis Medizintechnik GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com
• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250676743503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223542

FDA Product Code

• PNZ: Eustachian tube balloon dilation device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-15
• Device Publish Date: 2023-09-07

Devices Manufactured by Spiggle & Theis Medizintechnik GmbH

• 04050659354647 - Brünings anastignatic aural magnifier: 2026-01-29 set with mangnifier, ball, 4 specula case, 1 set
• 04250676747204 - Tray set with flex band and pier pin: 2026-01-21
• 04250676747211 - Tray set with flex band: 2026-01-21
• 04250676747235 - Filter modul with 8 x LM: 2026-01-21 and connection set, mountable
• 04250676747228 - Tray set: 2025-12-11 with flex band and reversible lid
• 04251993600128 - Filter modul with 8 x LM: 2025-12-11 and connection set, mountable
• 04251993601927 - Tray set with flex band and pier pin: 2025-12-11
• 04251993601934 - Tray set with flex band: 2025-12-11