Clavicle Plate, Lateral 3.5 mm 21127-6

GUDID 09120034309670

Clavicle Plate, Lateral 3.5 mm, 6-Hole, Right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034309670
NIH Device Record Key319f07fa-8bcd-40c3-b435-1548aade5b2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameClavicle Plate, Lateral 3.5 mm
Version Model Number21127-6
Catalog Number21127-6
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
GS109120034309670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


[09120034309670]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-06

On-Brand Devices [Clavicle Plate, Lateral 3.5 mm]

09120034309793Clavicle Plate, Lateral 3.5 mm, 6-Hole, Left
09120034309670Clavicle Plate, Lateral 3.5 mm, 6-Hole, Right

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