Symphysis Plate, Curved 21163-8

GUDID 09120047303009

Symphysis Plate, Curved, 8-Hole, PRS RX System

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120047303009
NIH Device Record Key78f15d5d-b08d-4840-9cc6-b73948065c75
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymphysis Plate, Curved
Version Model Number21163-8
Catalog Number21163-8
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
GS109120047303009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


[09120047303009]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-01

On-Brand Devices [Symphysis Plate, Curved]

09120047303009Symphysis Plate, Curved, 8-Hole, PRS RX System
09120047302330Symphysis Plate, Curved, 6-Hole, PRS RX System

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