FLS Plate, Straight 21422-5

GUDID 09120047299326

FLS Plate, Straight, 5-Hole, Long

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120047299326
NIH Device Record Key4b074da3-f02e-43e1-a491-1edab691ff3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLS Plate, Straight
Version Model Number21422-5
Catalog Number21422-5
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
GS109120047299326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

Moist Heat or Steam Sterilization


[09120047299326]

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, Straight]

09120047299333FLS Plate, Straight, 6-Hole
09120047299326FLS Plate, Straight, 5-Hole, Long
09120047298794FLS Plate, Straight, 5-Hole, Short

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