Trochar 118008-8

GUDID 09120047308387

Trochar, Cannulated Tibia a. Femur Nail

I.T.S. GmbH

Cannulated surgical drill bit, single-use
Primary Device ID09120047308387
NIH Device Record Key59ae8c46-9688-46bb-b392-57087ef1bacb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrochar
Version Model Number118008-8
Catalog Number118008-8
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120047308387 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


[09120047308387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-11-28
Device Publish Date2018-09-17

Devices Manufactured by I.T.S. GmbH

09120047301241 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=10mm, L=360mm
09120047301364 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=285mm
09120047301371 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=300mm
09120047301388 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=405mm
09120047301395 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=10mm, L=285mm
09120047301418 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=330mm
09120047301425 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=345mm
09120047301432 - Cannulated Tibia Nail2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=360mm

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.