Total Middle Ear Implants 11840

GUDID 04250381804032

Total middle ear implant, fixed size, titanium, oval-excentric head, 4.0x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial

• Primary Device ID: 04250381804032
• NIH Device Record Key: 75c2f1ac-ab4d-4870-8624-6d2c237c10d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Middle Ear Implants
• Version Model Number: 11840
• Catalog Number: 11840
• 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: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250381804032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030492

FDA Product Code

• ETA: Replacement, Ossicular Prosthesis, Total

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

• 04250381891940 - Metal bowl: 2025-06-02 B1 Ø 40 mm, height 19 mm, 20 ml
• 04250381892039 - Tablet dish: 2025-06-02 stainless steel Ø 65 mm, height 19 mm
• 04250381820421 - Expanding nasal tampon: 2025-05-29 PVA, straight 45x15x20 mm, sterile, 20 pieces/box
• 04250381820452 - Expanding nasal tampon: 2025-05-29 PVA, straight, with airway 45x15x20 mm, sterile, 20 pieces/box
• 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