Partial Middle Ear Implants 12820

GUDID 04250381805152

Partial middle ear implant, fixed size, titanium, oval-excentric head, slit bell, 2.0x0.3 mm, sterile, 1 piece

Spiggle & Theis Medizintechnik GmbH

Ossicular prosthesis, partial
Primary Device ID04250381805152
NIH Device Record Key7db84480-fe8e-40c9-a20d-aa938df11ffe
Commercial Distribution StatusIn Commercial Distribution
Brand NamePartial Middle Ear Implants
Version Model Number12820
Catalog Number12820
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

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
GS104250381805152 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-17
Device Publish Date2019-06-07

Devices Manufactured by Spiggle & Theis Medizintechnik GmbH

04250381821503 - Gillies skin hook2025-10-07 fine 18.5 cm
04250676710017 - Hook2025-10-07 curved, blunt 10.5 cm
04250676711625 - Fork2025-10-07 curved 10.5 cm
04250676716880 - ENT-single-use suction tubes, angled2025-10-07 transparent, Luer-Lock 130 x 2.0 mm, sterile, box of 50
04250676716897 - ENT-single-use suction tubes, angled2025-10-07 blue, Luer-Lock 130 x 3.0 mm, sterile, box of 50
04250676731982 - Salivary duct probe2025-10-07 straight, cylindrical 0.5 mm diameter
04250676731999 - Salivary duct probe2025-10-07 straight, cylindrical 0.6 mm diameter
04250676732002 - Salivary duct probe2025-10-07 straight, cylindrical 0.8 mm diameter

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