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 ID04250381804032
NIH Device Record Key75c2f1ac-ab4d-4870-8624-6d2c237c10d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Middle Ear Implants
Version Model Number11840
Catalog Number11840
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

Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104250381804032 [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

Devices Manufactured by Spiggle & Theis Medizintechnik GmbH

04250676739988 - Jackson laryngoscope2025-01-07 size 3, handle removable, light carrier satin finished inside, 180 mm long
04250676742056 - Blakesley nasal forceps, comfort2025-01-06 straight, golden button 4.0 mm, 12 cm
04250676742353 - Aufricht nasal retractor2025-01-06 for holding of suction tube 18.5 cm
04250676742360 - Suction tube2025-01-06 for Aufricht nasal retractor 18.5 cm
04250676744234 - Aufricht nasal retractor2025-01-06 including suction tube 18.5 cm
04250381814116 - Kerrison sphenoid punch2024-11-19 40° downw., golden tip, totally detach. 1 mm, 18 cm
04250676725561 - Kerrison sphenoid punch2024-11-19 90° upw., golden tip, totally detachable 1 mm, 23 cm
04250676725974 - Kerrison sphenoid punch2024-11-19 40° upw., golden tip, totally detachable 1 mm, 20 cm

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