Radius Plate PROlock, Wide 21025-4

GUDID 09120034303227

Radius Plate PROlock, Wide, 4-Hole, Right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034303227
NIH Device Record Key4013b8d2-9a3e-4a09-b5e0-89da9833d827
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadius Plate PROlock, Wide
Version Model Number21025-4
Catalog Number21025-4
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
GS109120034303227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


[09120034303227]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-08
Device Publish Date2016-09-06

On-Brand Devices [Radius Plate PROlock, Wide]

09120034304323Radius Plate PROlock, Wide, 10-Hole, Left
09120034304316Radius Plate PROlock, Wide, 10-Hole, Right
09120034304286Radius Plate PROlock, Wide, 8-Hole, Left
09120034304279Radius Plate PROlock, Wide, 8-Hole, Right
09120034303227Radius Plate PROlock, Wide, 4-Hole, Right
09120034303210Radius Plate PROlock, Wide, 6-Hole, Right
09120034303203Radius Plate PROlock, Wide, 4-Hole, Left
09120034303197Radius Plate PROlock, Wide, 6-Hole, Left

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