TubaInsert® - Type 45° 2080-2045-US

GUDID 04250676743527

Spiggle & Theis Medizintechnik GmbH

Peripheral vascular guidewire, manual

• Primary Device ID: 04250676743527
• NIH Device Record Key: e8464c0f-2dd1-4b82-a490-85f4c20673fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubaInsert® - Type 45°
• Version Model Number: 2080-2045-US
• Catalog Number: 2080-2045-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	04250676743527 [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

• 04250381821503 - Gillies skin hook: 2025-10-07 fine 18.5 cm
• 04250676710017 - Hook: 2025-10-07 curved, blunt 10.5 cm
• 04250676711625 - Fork: 2025-10-07 curved 10.5 cm
• 04250676716880 - ENT-single-use suction tubes, angled: 2025-10-07 transparent, Luer-Lock 130 x 2.0 mm, sterile, box of 50
• 04250676716897 - ENT-single-use suction tubes, angled: 2025-10-07 blue, Luer-Lock 130 x 3.0 mm, sterile, box of 50
• 04250676731982 - Salivary duct probe: 2025-10-07 straight, cylindrical 0.5 mm diameter
• 04250676731999 - Salivary duct probe: 2025-10-07 straight, cylindrical 0.6 mm diameter
• 04250676732002 - Salivary duct probe: 2025-10-07 straight, cylindrical 0.8 mm diameter