TubaInsert® - Type 45° 2080-2045-US

GUDID 04250676743527

Spiggle & Theis Medizintechnik GmbH

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• 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

• 04250676721624 - Reynolds scissors: 2024-01-15 supercut, curved, blunt 18 cm
• 04250676734488 - Walter scissors: 2024-01-15 angled, pointed 10 cm
• 04250676740069 - Metzenbaum scissors, Premium Line: 2024-01-15 straight, blunt 14.5 cm
• 04250676740076 - Metzenbaum scissors, Premium Line: 2024-01-15 straight, blunt 18 cm
• 04250676740083 - Metzenbaum scissors, Premium Line: 2024-01-15 straight, blunt 20 cm
• 04250676740090 - Metzenbaum scissors, Premium Line: 2024-01-15 curved, blunt 14.5 cm
• 04250676740106 - Metzenbaum scissors, Premium Line: 2024-01-15 curved, blunt 18 cm
• 04250676740113 - Metzenbaum scissors, Premium Line: 2024-01-15 curved, blunt 20 cm