Total Middle Ear Implant 11945

GUDID 04250381804230

Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial

• Primary Device ID: 04250381804230
• NIH Device Record Key: 2c616765-c668-4f07-a2ff-6dd445514071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Middle Ear Implant
• Version Model Number: 11945
• Catalog Number: 11945
• 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: false
• 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: 4.5 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	04250381804230 [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

On-Brand Devices [Total Middle Ear Implant]

• 04250381804261: Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile
• 04250381804278: Total middle ear implant, fixed size, titanium, round-centric head, 6.0x0.3 mm, sterile, 1 piece
• 04250381804230: Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, sterile, 1 piece
• 04250381804179: Total middle ear implant, fixed size, titanium, oval-excentric head, 7.0x0.3 mm, sterile, 1 piec
• 04250381804025: Total middle ear implant, fixed size, titanium, oval-excentric head, 3.5x0.3 mm, sterile, 1 piec
• 04250381803943: Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.3x0.4 mm, sterile, 1 p
• 04250381803912: Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.8x0.4 mm, sterile, 1 p
• 04250381803899: Total middle ear implant, shortenable, titanium, with head, 7.0x0.3 mm, sterile, 1 piece
• 04250381803882: Total middle ear implant, shortenable, titanium, with head, 7.5x0.3 mm, sterile, 1 piece
• 04250381803790: Total middle ear implant, shortenable, titanium, with shoe, 7.3x0.4 mm, sterile, 1 piece
• 04250381803738: Total middle ear implant, shortenable, titanium, with shoe, 7.8x0.4 mm, sterile, 1 piece