4740009

GUDID 07613327384932

STERNALPLATE, STRAIGHT, 4 HOLE

Stryker Leibinger GmbH & Co. KG

Sternal fixation device
Primary Device ID07613327384932
NIH Device Record Key107b5ce4-b7eb-4020-9a06-4b10ee98701a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4740009
Catalog Number4740009
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327384932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327384932]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-24
Device Publish Date2019-04-16

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327634952 - NA2024-12-16 Drill for 6514-7-200 WL 16mm
07613327634969 - NA2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634976 - NA2024-12-16 Drill for 6514-7-200 WL 10mm
07613327634983 - NA2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634990 - NA2024-12-16 Drill for 6514-7-200 14mm
07613327635003 - NA2024-12-16 Drill for 6514-7-200 WL 10mm
07613327635010 - NA2024-12-16 Drill for 6514-7-200 WL 14mm
07613327651058 - NA2024-11-20 T-plate malleable left

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.