Partial Middle Ear Implant 12920

GUDID 04250381805251

Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 2.0x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial
Primary Device ID04250381805251
NIH Device Record Key015ed023-3e23-485b-8280-35ad35e8bf94
Commercial Distribution StatusIn Commercial Distribution
Brand NamePartial Middle Ear Implant
Version Model Number12920
Catalog Number12920
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49220690810
Emailinfo@spiggle-theis.de

Device Dimensions

Length2 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
GS104250381805251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBProsthesis, Partial Ossicular Replacement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-04

On-Brand Devices [Partial Middle Ear Implant]

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04250381805251Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 2.0x0.3 mm, s
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04250381805213Partial middle ear implant, fixed size, titanium, round-centric head, unslit bel, 1.0x0.3 mm, st
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04250381805077Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.5x0.3 mm, ste
04250381805060Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.25x0.3 mm, st
04250381805053Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 2.0x0.3 mm, ste
04250381805039Partial middle ear implant, fixed size, titanium, round-centric head, slit bell, 1.5x0.3 mm, ste

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