Partial Middle Ear Implant 12917

GUDID 04250381805244

Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.75x0.3 mm, sterile

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial

• Primary Device ID: 04250381805244
• NIH Device Record Key: 6fcfb74e-2280-4899-8442-fafc9dbdfa64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Partial Middle Ear Implant
• Version Model Number: 12917
• Catalog Number: 12917
• 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: false
• 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: +49220690810
• Email: info@spiggle-theis.de

Device Dimensions

• Length: 1.75 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	04250381805244 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-04

On-Brand Devices [Partial Middle Ear Implant]

• 04250381805299: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 3.5x0.3 mm, s
• 04250381805282: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 3.0x0.3 mm, s
• 04250381805275: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 2.5x0.3 mm, s
• 04250381805251: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 2.0x0.3 mm, s
• 04250381805244: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.75x0.3 mm,
• 04250381805237: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.5x0.3 mm, s
• 04250381805206: Partial middle ear implant, fixed size, titanium round-centric head, unslit bell, 0.5x0.3 mm, st
• 04250381804650: Partial middle ear implant, shortenable, titanium, with head, 5.0x0.3 mm, sterile
• 04250381804582: Partial middle ear implant, shortenable, titanium, with head, 5.5x0.3 mm, sterile
• 04250381805213: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bel, 1.0x0.3 mm, st
• 04250381805084: Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 3.0x0.3 mm, ste
• 04250381805077: Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.5x0.3 mm, ste
• 04250381805060: Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.25x0.3 mm, st
• 04250381805053: Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.0x0.3 mm, ste
• 04250381805039: Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 1.5x0.3 mm, ste