Proximal Humeral Plate, Standard, 10-Hole

GUDID 09120116972174

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120116972174
NIH Device Record Key4a12fb3d-a88c-4cc1-bbea-9272bbb86f7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Humeral Plate, Standard, 10-Hole
Version Model Number211341-10
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS109120116972174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


[09120116972174]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-08-08
Device Publish Date2022-12-27

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