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

• 04250381810255 - External aluminium nasal splint: 2025-10-06 66x42x45 mm, large, self-adhesive 10 pieces/box
• 04250676708861 - Brünings septal forceps: 2025-10-06 size 2
• 04250676708878 - Brünings septal forceps: 2025-10-06 size 1
• 04250676716309 - Grünwald-Henke punch: 2025-10-06 size 1, straight 3.0 mm, 11.5 cm
• 04250676731142 - Chisel: 2025-10-06 with scale, very delicate 6 mm, 24 cm
• 04250676731159 - Chisel: 2025-10-06 with scale, very delicate 8 mm, 24 cm
• 04250676731166 - Chisel: 2025-10-06 with scale, very delicate 12 mm, 24 cm
• 04250676731173 - Chisel: 2025-10-06 with scale, very delicate 15 mm, 24 cm