Forearm Plate, Straight 21605-6

GUDID 09120047307175

Forearm Plate, Straight, 6-Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120047307175
NIH Device Record Keyd2c4016f-4369-44de-a948-e206eaec8e8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameForearm Plate, Straight
Version Model Number21605-6
Catalog Number21605-6
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120047307175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


[09120047307175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-08
Device Publish Date2016-09-08

On-Brand Devices [Forearm Plate, Straight]

09120047307182Forearm Plate, Straight, 11-Hole
09120047307175Forearm Plate, Straight, 6-Hole
09120047307168Forearm Plate, Straight, 9-Hole

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.