TubaVent® balloon dilatation system 2080-3045-US

GUDID 04250676745088

TubaInsert ONE® - Type 45°, insertion device, sterile, 10 pieces

Spiggle & Theis Medizintechnik GmbH

Peripheral vascular guidewire, manual

• Primary Device ID: 04250676745088
• NIH Device Record Key: 72c55ca9-805a-4d77-906f-7223da02777d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubaVent® balloon dilatation system
• Version Model Number: 2080-3045-US
• Catalog Number: 2080-3045-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250676745088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223542

FDA Product Code

• PNZ: Eustachian tube balloon dilation device

Sterilization

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

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

[04250676745088]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-07
• Device Publish Date: 2025-02-27

Devices Manufactured by Spiggle & Theis Medizintechnik GmbH

• 04250676745088 - TubaVent® balloon dilatation system: 2025-03-07TubaInsert ONE® - Type 45°, insertion device, sterile, 10 pieces
• 04250676745088 - TubaVent® balloon dilatation system: 2025-03-07 TubaInsert ONE® - Type 45°, insertion device, sterile, 10 pieces
• 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