Fibula Plate Distal, 5-Hole 21223-5

GUDID 09120069817089

Fibula Plate Distal, 5-Hole, Right

I.T.S. GmbH

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID09120069817089
NIH Device Record Key057fe0be-52cd-4c7c-93b2-0b5e79358f1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibula Plate Distal, 5-Hole
Version Model Number21223-5
Catalog Number21223-5
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
GS109120069817089 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120069817089]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-28
Device Publish Date2020-04-20

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