Partial Middle Ear Implants 12820

GUDID 04250381805152

Partial middle ear implant, fixed size, titanium, oval-excentric head, slit bell, 2.0x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial

• Primary Device ID: 04250381805152
• NIH Device Record Key: 7db84480-fe8e-40c9-a20d-aa938df11ffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Partial Middle Ear Implants
• Version Model Number: 12820
• Catalog Number: 12820
• Company DUNS: 332893028
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +492206908153
• Email: p.stockmann@spiggle-theis.com

Device Dimensions

• Length: 2 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage must protect from dust, moisture and contamination. Avoid direct Sunlight during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250381805152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030492

FDA Product Code

• ETB: Prosthesis, Partial Ossicular Replacement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-17
• Device Publish Date: 2019-06-07

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