FLS Plate, L-Shape 21442

GUDID 09120047298763

FLS Plate, L-Shape, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120047298763
NIH Device Record Key002dbc81-6507-4edc-b738-8f0b7abaf56a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLS Plate, L-Shape
Version Model Number21442
Catalog Number21442
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
GS109120047298763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


[09120047298763]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [FLS Plate, L-Shape]

09120047299388FLS Plate, L-Shape, Extended 45°, Left
09120047299371FLS Plate, L-Shape,Extended 1mm Step, Left
09120047299364FLS Plate, L-Shape, Extended, Left
09120047298862FLS Plate, L-Shape, Extended 45°, Right
09120047298855FLS Plate, L-Shape,Extended 1mm Step, Right
09120047298848FLS Plate, L-Shape, Extended, Right
09120047298763FLS Plate, L-Shape, Left
09120047298756FLS Plate, L-Shape, Right

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