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

• 04250676739988 - Jackson laryngoscope: 2025-01-07 size 3, handle removable, light carrier satin finished inside, 180 mm long
• 04250676742056 - Blakesley nasal forceps, comfort: 2025-01-06 straight, golden button 4.0 mm, 12 cm
• 04250676742353 - Aufricht nasal retractor: 2025-01-06 for holding of suction tube 18.5 cm
• 04250676742360 - Suction tube: 2025-01-06 for Aufricht nasal retractor 18.5 cm
• 04250676744234 - Aufricht nasal retractor: 2025-01-06 including suction tube 18.5 cm
• 04250381814116 - Kerrison sphenoid punch: 2024-11-19 40° downw., golden tip, totally detach. 1 mm, 18 cm
• 04250676725561 - Kerrison sphenoid punch: 2024-11-19 90° upw., golden tip, totally detachable 1 mm, 23 cm
• 04250676725974 - Kerrison sphenoid punch: 2024-11-19 40° upw., golden tip, totally detachable 1 mm, 20 cm