Olecranon Plate 21111-10

GUDID 09120034303036

Olecranon Plate, 10 Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034303036
NIH Device Record Keye859b2ec-3c39-40ec-a982-2509e641b2e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlecranon Plate
Version Model Number21111-10
Catalog Number21111-10
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
GS109120034303036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


[09120034303036]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-07

On-Brand Devices [Olecranon Plate]

09120034303036Olecranon Plate, 10 Hole
09120034303029Olecranon Plate, 12 Hole
09120034303012Olecranon Plate, 6 Hole
09120034303005Olecranon Plate, 8 Hole

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