Total Middle Ear Implant 11400

GUDID 04250381803899

Total middle ear implant, shortenable, titanium, with head, 7.0x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial
Primary Device ID04250381803899
NIH Device Record Keye078eb3f-523e-4f32-bd21-bbcc2709c5ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Middle Ear Implant
Version Model Number11400
Catalog Number11400
Company DUNS332893028
Company NameSpiggle & Theis Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+492206908153
Emailp.stockmann@spiggle-theis.com

Device Dimensions

Length7 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage must protect from dust, moisture and contamination. Avoid direct Sunlight during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS104250381803899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETAReplacement, Ossicular Prosthesis, Total

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-17
Device Publish Date2019-06-07

On-Brand Devices [Total Middle Ear Implant]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.