Fibula Plate PROlock 21222-4

GUDID 09120034302640

Fibula Plate PROlock, 4-Hole, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034302640
NIH Device Record Key8712c981-9387-4e01-bbef-ad303037540c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibula Plate PROlock
Version Model Number21222-4
Catalog Number21222-4
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
GS109120034302640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


[09120034302640]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [Fibula Plate PROlock]

09120034302671Fibula Plate PROlock, 4-Hole, Right
09120034302664Fibula Plate PROlock, 6-Hole, Right
09120034302657Fibula Plate PROlock, 8-Hole, Right
09120034302640Fibula Plate PROlock, 4-Hole, Left
09120034302633Fibula Plate PROlock, 6-Hole, Left
09120034302626Fibula Plate PROlock, 8-Hole, Left

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