Hexagon-Shank KM 48-348

GUDID 09120034306440

Hexagon-Shank, WS 2.5,L=135mm, AO Connector

I.T.S. GmbH

Surgical instrument torque limiter
Primary Device ID09120034306440
NIH Device Record Keyc7d99462-2ace-43dc-91c0-0b65088690ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameHexagon-Shank
Version Model NumberKM 48-348
Catalog NumberKM 48-348
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS109120034306440 [Primary]

FDA Product Code

LRZScrewdriver, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


[09120034306440]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-10-01
Device Publish Date2018-11-13

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.